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Argon Medical Devices Inc.

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Web: http://www.argonmedical.com
E-Mail:
Address: 1445 Flat Creek Road, Athens, Texas 75751, USA
Phone: +1-(903)-675-9321, 800-927-4669 | Fax: +1-(903)-677-9396 | Map/Directions >>
 
 

Profile: Argon Medical Devices Inc. manufactures and supplies single-use vascular access devices. Our products are divided into cardiology, radiology and critical care product lines. Our products include arterial needles, dilators, obturators and endomyocardial biopsy forceps. We market disposable devices to cardiac cath-labs, radiology labs and critical care units. Our endomyocardial biopsy forceps provide accuracy, reliability and flexibility. The alloy cutting jaws are precision machined to provide a cleanly cut specimen every time. The proven handle tension spring design insures consistent jaw closure during withdrawal. Pre-curved, maxi-curve or straight EMB forcep configurations provide maximum flexibility of choice for precise jaw positioning. Three-ringed handle easily adapts to any thumb position enabling a clinician's hand to angle like with an ergonomically designed pair of scissors that cause less fatigue and offer more control. This single-use, disposable unit eliminates the risk of cross contamination.

FDA Registration Number: 1625425

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• Guide Wire Accessories
• Guidewire Catheter (FDA Code: DQX / 870.1330)
A catheter guide wire is a coiled wire that is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel.
• Hemodialysis Blood Circuit Accessories (FDA Code: KOC / 876.5820)
A hemodialysis system and accessories is a device that is used as an artificial kidney system for the treatment of patients with renal failure or toxemic conditions and that consists of an extracorporeal blood system, a conventional dialyzer, a dialysate delivery system, and accessories. Blood from a patient flows through the tubing of the extracorporeal blood system and accessories to the blood compartment of the dialyzer, then returns through further tubing of the extracorporeal blood system to the patient. The dialyzer has two compartments that are separated by a semipermeable membrane. While the blood is in the blood compartment, undesirable substances in the blood pass through the semipermeable membrane into the dialysate in the dialysate compartment. The dialysate delivery system controls and monitors the dialysate circulating through the dialysate compartment of the dialyzer.
• High Pressure Injection
• Hydraulic Cystometric Device (FDA Code: FEN / 876.1620)
A urodynamics measurement system is a device used to measure volume and pressure in the urinary bladder when it is filled through a catheter with carbon dioxide or water. The device controls the supply of carbon dioxide or water and may also record the electrical activity of the muscles associated with urination. The device system may include transducers, electronic signal conditioning and display equipment, a catheter withdrawal device to enable a urethral pressure profile to be obtained, and special catheters for urethral profilometry and electrodes for electromyography. This generic type of device includes the cystometric gas (carbon dioxide) device, the cystometric hydrualic device, and the electrical recording cystometer, but excludes any device that uses air to fill the bladder.
• Implantable Venous Access Catheter Introducer Kits
• Intrauterine Pressure Transducer (FDA Code: HFN / 884.2700)
An intrauterine pressure monitor is a device designed to detect and measure intrauterine and amniotic fluid pressure with a catheter placed transcervically into the uterine cavity. The device is used to monitor intensity, duration, and frequency of uterine contractions during labor. This generic type of device may include the following accessories: signal analysis and display equipment, patient and equipment supports, and component parts.
• Intravenous Administration Kit (FDA Code: FPA / 880.5440)
An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container.
• Irrigation Sets & Tubing
• Lead (Dedicated Instruments) Fluorometer (FDA Code: DOX / 862.3550)
A lead test system is a device intended to measure lead, a heavy metal, in blood and urine. Measurements obtained by this device are used in the diagnosis and treatment of lead poisoning.
• Microdissection Needle Electrodes
• Modified Vascular Clamp
• Multiple Lumen Catheter (FDA Code: GBP / 878.4200)
An introduction/drainage catheter is a device that is a flexible single or multilumen tube intended to be used to introduce nondrug fluids into body cavities other than blood vessels, drain fluids from body cavities, or evaluate certain physiologic conditions. Examples include irrigation and drainage catheters, pediatric catheters, peritoneal catheters (including dialysis), and other general surgical catheters. An introduction/drainage catheter accessory is intended to aid in the manipulation of or insertion of the device into the body. Examples of accessories include adaptors, connectors, and catheter needles.
• Needle Electrode (FDA Code: GXZ / 882.1350)
A needle electrode is a device which is placed subcutaneously to stimulate or to record electrical signals.
• Neonatal Vascular Clamp
• Nonstick Needle Electrode
• Percutaneous Catheter (FDA Code: DQY / 870.1250)
A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.
• Percutaneous Catheterization Vessel Dilator (FDA Code: DRE / 870.1310)
A vessel dilator for percutaneous catheterization is a device which is placed over the guide wire to enlarge the opening in the vessel, and which is then removed before sliding the catheter over the guide wire.
• Percutaneous Catheters Sets, Pediatric
• Percutaneous Catheters Sets, Pediatric Percutaneous Access
• Percutaneous Entry Needle With Vented Stylet
• Peripheral Vascular Clamps
• Piston Syringe (FDA Code: FMF / 880.5860)
A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.
• PTFE Coated and Stainless Steel Guide Wires
• Reusable Concentric Needle Electrodes
• Reusable Monopolar Needle Electrodes
• Reusable Single Fiber Needle Electrode
• Scalp Circular Electrode and Applicator (FDA Code: HGP / 884.2675)
A fetal scalp circular (spiral) electrode and applicator is a device used to obtain a fetal electrocardiogram during labor and delivery. It establishes electrical contact between fetal skin and an external monitoring device by a shallow subcutaneous puncture of fetal scalp tissue with a curved needle or needles. This generic type of device includes nonreusable spiral electrodes and reusable circular electrodes.
• Scalpel Blade (FDA Code: GES / 878.4800)
A manual surgical instrument for general use is a nonpowered, hand-held, or hand-manipulated device, either reusable or disposable, intended to be used in various general surgical procedures. The device includes the applicator, clip applier, biopsy brush, manual dermabrasion brush, scrub brush, cannula, ligature carrier, chisel, clamp, contractor, curette, cutter, dissector, elevator, skin graft expander, file, forceps, gouge, instrument guide, needle guide, hammer, hemostat, amputation hook, ligature passing and knot-tying instrument, knife, blood lancet, mallet, disposable or reusable aspiration and injection needle, disposable or reusable suturing needle, osteotome, pliers, rasp, retainer, retractor, saw, scalpel blade, scalpel handle, one-piece scalpel, snare, spatula, stapler, disposable or reusable stripper, stylet, suturing apparatus for the stomach and intestine, measuring tape, and calipers. A surgical instrument that has specialized uses in a specific medical specialty is classified in separate regulations in parts 868 through 892.
• Sharpening Kit for Reusable Needle Electrodes
• Short-Term Less Than 30 Days Therapeutic Intravascular Catheter (FDA Code: FOZ / 880.5200)
An intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings and that is inserted into the patient's vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously. The device may be constructed of metal, rubber, plastic, or a combination of these materials.
• Single Handed Scalpel Blade Remover
• Single Lumen Hypodermic Needle (FDA Code: FMI / 880.5570)
A hypodermic single lumen needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe or an intravascular administration set.
• Single-Use Peritoneal Dialysis Catheter (FDA Code: FKO / 876.5630)
(1) A peritoneal dialysis system and accessories is a device that is used as an artificial kidney system for the treatment of patients with renal failure or toxemic conditions, and that consists of a peritoneal access device, an administration set for peritoneal dialysis, a source of dialysate, and, in some cases, a water purification mechanism. After the dialysate is instilled into the patient's peritoneal cavity, it is allowed to dwell there so that undesirable substances from the patient's blood pass through the lining membrane of the peritoneal cavity into this dialysate. These substances are then removed when the dialysate is drained from the patient. The peritoneal dialysis system may regulate and monitor the dialysate temperature, volume, and delivery rate together with the time course of each cycle of filling, dwell time, and draining of the peritoneal cavity or manual controls may be used. This generic device includes the semiautomatic and the automatic peritoneal delivery system.
• Specialized Obstetric-Gynecologic Manual Instrument (FDA Code: KNA / 884.4530)
An obstetric-gynecologic specialized manual instrument is one of a group of devices used during obstetric-gynecologic procedures to perform manipulative diagnostic and surgical functions (e.g., dilating, grasping, measuring, and scraping), where structural integrity is the chief criterion of device performance. This type of device consists of the following:
• Sterile Surgical Drapes (FDA Code: KKX / 878.4370)
A surgical drape and drape accessories is a device made of natural or synthetic materials intended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial and other contamination. The device includes a plastic wound protector that may adhere to the skin around a surgical incision or be placed in a wound to cover its exposed edges, and a latex drape with a self-retaining finger cot that is intended to allow repeated insertion of the surgeon's finger into the rectum during performance of a transurethral prostatectomy.
• Sudan IV (FDA Code: KKK / 864.1850)
Dye and chemical solution stains for medical purposes are mixtures of synthetic or natural dyes or nondye chemicals in solutions used in staining cells and tissues for diagnostic histopathology, cytopathology, or hematology.
• Surgical Drapes (FDA Code: KKX / 878.4370)
• Surgical Drapes & Packs (FDA Code: KKX / 878.4370)
• Surgical Gowns (FDA Code: FYA / 878.4040)
Surgical apparel are devices that are intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. Examples include surgical caps, hoods, masks, gowns, operating room shoes and shoe covers, and isolation masks and gowns. Surgical suits and dresses, commonly known as scrub suits, are excluded.
• Surgical Needle Guide (FDA Code: GDF / 878.4800)
• Syringe/Needle Combos
• Temporary Pacemaker Electrode (FDA Code: LDF / 870.3680)
A temporary pacemaker electrode is a device consisting of flexible insulated electrical conductors with one end connected to anexternal pacemaker pulse generator and the other end applied to the heart. The device is used to transmit a pacing electrical stimulus from the pulse generator to the heart and/or to transmit the electrical signal of the heart to the pulse generator.
• Therapeutic Intravascular Catheter (FDA Code: LJS / 880.5970)
A percutaneous, implanted, long-term intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings, such as luer hubs, and accessories that facilitate the placement of the device. The device allows for repeated access to the vascular system for long-term use of 30 days or more, and it is intended for administration of fluids, medications, and nutrients; the sampling of blood; and monitoring blood pressure and temperature. The device may be constructed of metal, rubber, plastic, composite materials, or any combination of these materials and may be of single or multiple lumen design.
• Thermodilution Probe (FDA Code: KRB / 870.1915)
A thermodilution probe is a device that monitors cardiac output by use of thermodilution techniques; this device is commonly attached to a catheter that may have one or more probes.
• Titanium Cardiovascular Clamps
• Twisted Disposable Subdermal Needle Electrodes
• Umbilical Artery Catheter (FDA Code: FOS / 880.5200)
• Urological Catheter Care Kits
• Urological Catheters (FDA Code: KOD / 876.5130)
A urological catheter and accessories is a flexible tubular device that is inserted through the urethra and used to pass fluids to or from the urinary tract. This generic type of device includes radiopaque urological catheters, ureteral catheters, urethral catheters, coudecatheters, balloon retention type catheters, straight catheters, upper urinary tract catheters, double lumen female urethrographic catheters, disposable ureteral catheters, male urethrographic catheters, and urological catheter accessories including ureteral catheter stylets, ureteral catheter adapters, ureteral catheter holders, ureteral catheter stylets, ureteral catheterization trays, and the gastro-urological irrigation tray (for urological use).

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