Profile: Boston Scientific Corporation specializes in the development, manufacturing and marketing of medical devices. We also design and produce cardiovascular medical products. Our cardiovascular division concentrates on providing medical treatment to cardiovascular, peripheral vascular & neurovascular diseases, cardiac arrhythmias, neurological disorders, neuro and aortic aneurysms and acute myocardial infarction. Our Contak Renewal®TR cardiac resynchronization therapy pacemaker (CRT-P), Models H120 and H125, is designed to provide cardiac resynchronization therapy (CRT). Cardiac resynchronization therapy is for the treatment of heart failure (HF) and uses biventricular electrical stimulation to synchronize ventricular contractions. Our Altrua™ pacemakers deliver the benefits of natural pacing by accurately sensing and responding to the body's signals.

FDA Registration Number: 1828132

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• Fluid Evacuator System (FDA Code: FHF / 876.4370) A gastroenterology-urology evacuator is a device used to remove debris and fluids during gastroenterological and urological procedures by drainage, aspiration, or irrigation. This generic type of device includes the fluid evacuator system, manually powered bladder evacuator, and the AC-powered vacuum pump.

• Foley Catheter Introducer

• Forceps Needle Holders

• Gastro-Enterostomy Tube (FDA Code: KGC / 876.5980) A gastrointestinal tube and accessories is a device that consists of flexible or semi-rigid tubing used for instilling fluids into, withdrawing fluids from, splinting, or suppressing bleeding of the alimentary tract. This device may incorporate an integral inflatable balloon for retention or hemostasis. This generic type of device includes the hemostatic bag, irrigation and aspiration catheter (gastric, colonic, etc.), rectal catheter, sterile infant gavage set, gastrointestinal string and tubes to locate internal bleeding, double lumen tube for intestinal decompression or intubation, feeding tube, gastroenterostomy tube, Levine tube, nasogastric tube, single lumen tube with mercury weight balloon for intestinal intubation or decompression, and gastro-urological irrigation tray (for gastrological use).

• Gastro-Urology Catheter & Accessories (FDA Code: KNY / 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).

• Gastro-Urology Evacuator (FDA Code: KQT / 876.4370)

• Gastro-Urology Needle (FDA Code: FHR / 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.

• Gastro-Urology Stylet (FDA Code: EZB / 876.5130)

• Gastroenterologic Needle Holder (FDA Code: FHQ / 876.4730) A manual gastroenterology-urology surgical instrument and accessories is a device designed to be used for gastroenterological and urological surgical procedures. The device may be nonpowered, hand-held, or hand-manipulated. Manual gastroenterology-urology surgical instruments include the biopsy forceps cover, biopsy tray without biopsy instruments, line clamp, nonpowered rectal probe, nonelectrical clamp, colostomy spur-crushers, locking device for intestinal clamp, needle holder, gastro-urology hook, gastro-urology probe and director, nonself-retaining retractor, laparotomy rings, nonelectrical snare, rectal specula, bladder neck spreader, self-retaining retractor, and scoop.

• Gastroenterology-Urology Endoscopic Ultrasound System (FDA Code: ODG / 876.1500) An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.

• Gastrointestinal Tube and Accessories (FDA Code: KNT / 876.5980)

• General & Plastic Surgery Biopsy Brush (FDA Code: GEE / 878.4800)

• General & Plastic Surgery Laparoscope (FDA Code: GCJ / 876.1500)

• General & Plastic Surgery Nephrostomy Catheter (FDA Code: GBO / 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.

• General & Plastic Surgery Surgical Cannula (FDA Code: GEA / 878.4800)

• General & Plastic Surgery Surgical Dissector (FDA Code: GDI / 878.4800)

• General Medical Imaging

• General Medical Imaging Accessories

• General Surgical Manual Instrument (FDA Code: MDM / 878.4800)

• Genitourinary, Catheter Guide

• Guide Catheter 100cm Brachial - Radial

• Guide Catheter, Brachial

• Guide Catheter, Kimnyr

• Guide Catheter, Kimnyr Type Straight

• Guide Catheter, LCB

• Guide Catheter, LCB Type, Bypass

• Guide Catheter, LCB Type, Coronary Bypass

• Guide Catheter, LCB-side holes

• Guide Catheter, LCB-side holes 90 cm Guides

• Guide Catheter, Left and Right Coronary Bypass Curve

• Guide Catheter, MUTAT Right Curve

• Guide Catheter, Radial Curve

• Guide Catheter, Radial Flex Curve

• Guide Catheter, Radial High Take-Off Curve

• Guide Catheter, Radial Short Tip

• Guide Catheter, RCB

• Guide Catheter, Right Coronary Bypass, Side Holes

• Guide Catheter, Voda Left

• Guide Catheter, Voda Rightr Shepherds Crook

• 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.

• Gynecologic Laparoscope and Accessories (FDA Code: HET / 884.1720) A gynecologic laparoscope is a device used to permit direct viewing of the organs within the peritoneum by a telescopic system introduced through the abdominal wall. It is used to perform diagnostic and surgical procedures on the female genital organs. This generic type of device may include: Trocar and cannula, instruments used through an operating channel, scope preheater, light source and cables, and component parts.

• Heart Biopsy Forceps

• Heart Stabilizer (FDA Code: MWS / 870.4500) Cardiovascular surgical instruments are surgical instruments that have special features for use in cardiovascular surgery. These devices include, e.g., forceps, retractors, and scissors.

• Hemorrhoidal Ligator (FDA Code: FHN / 876.4400) A hemorrhoidal ligator is a device used to cut off the blood flow to hemorrhoidal tissue by means of a ligature or band placed around the hemorrhoid.

• Hexagonal Needle Holder

• High-Density Array Intracardiac Mapping Catheter (FDA Code: MTD / 870.1220) An electrode recording catheter or an electrode recording probe is a device used to detect an intracardiac electrocardiogram, or to detect cardiac output or left-to-right heart shunts. The device may be unipolar or multipolar for electrocardiogram detection, or may be a platinum-tipped catheter which senses the presence of a special indicator for cardiac output or left-to-right heart shunt determinations.

• Hole Catheter

• Image-Intensified Fluoroscopic X-Ray System (FDA Code: JAA / 892.1650) An image-intensified fluoroscopic x-ray system is a device intended to visualize anatomical structures by converting a pattern of x-radiation into a visible image through electronic amplification. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

• Implantable Endocardial Pacemaker Lead

• Implantable Venous Access Catheter Introducer Kits