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
• Rotablator Advancer, Exchangeable system |
• Rotating Uterine Biopsy Forceps |
• Rotational Atherectomy |
• Semi Rigid biopsy forceps |
• Serrated Jaws Carbide Jaw Needle Holder |
• Silicone Penrose Drainage Tube |
• Silicone T-Y Drainage Tube |
• Silicone Y-Drainage Tube |
• Single Chamber Implantable Pulse-Generator (FDA Code: LWO) |
• Single use VacutainerT Needle Holder |
• Single-Use Needle Holder |
• Sinus Endoscopy, Needle Holders |
• Small Diameter Vascular Graft Prosthesis (FDA Code: DYF / 870.3450) A vascular graft prosthesis is an implanted device intended to repair, replace, or bypass sections of native or artificial vessels, excluding coronary or cerebral vasculature, and to provide vascular access. It is commonly constructed of materials such as polyethylene terephthalate and polytetrafluoroethylene, and it may be coated with a biological coating, such as albumin or collagen, or a synthetic coating, such as silicone. The graft structure itself is not made of materials of animal origin, including human umbilical cords. |
• Soft Tissue Non-Biodegradable Fixation Fastener (FDA Code: MBI / 888.3040) A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system. |
• Special Procedure Angiographic Kit |
• Specialty Patient Examination Glove (FDA Code: LZC / 880.6250) A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. |
• Stainless Steel Needle Holders |
• Standard Needle Holders |
• Standard Oval Biopsy Forceps |
• Steerable Catheter (FDA Code: DRA / 870.1280) A steerable catheter is a catheter used for diagnostic and monitoring purposes whose movements are directed by a steering control unit. |
• Stent Systems Stainless Steel |
• Sterile Single-Use Angiographic Catheter |
• Straight Carbide Jaw Needle Holder |
• Suprapubic Catheter and Accessories (FDA Code: KOB / 876.5090) A suprapubic urological catheter and accessories is a flexible tubular device that is inserted through the abdominal wall into the urinary bladder with the aid of a trocar and cannula. The device is used to pass fluids to and from the urinary tract. This generic type of device includes the suprapubic catheter and tube, Malecot catheter, catheter punch instrument, suprapubic drainage tube, and the suprapubic cannula and trocar. |
• Suprapubic Tube Drainage (FDA Code: FFA / 876.5090) |
• Surgical Biliary Catheter (FDA Code: GCA / 876.5010) A biliary catheter and accessories is a tubular flexible device used for temporary or prolonged drainage of the biliary tract, for splinting of the bile duct during healing, or for preventing stricture of the bile duct. This generic type of device may include a bile collecting bag that is attached to the biliary catheter by a connector and fastened to the patient with a strap. |
• Surgical Needle Guide (FDA Code: GDF / 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. |
• Surgical Urethral Catheter (FDA Code: GBM / 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). |
• Suture Retention Device (FDA Code: KGS / 878.4930) A suture retention device is a device, such as a retention bridge, a surgical button, or a suture bolster, intended to aid wound healing by distributing suture tension over a larger area in the patient. |
• Synthetic Arterial Graft Prosthesis (Greater than 6mm) |
• Synthetic Arterial Graft Prosthesis (Less Than 6mm) |
• Synthetic/Biological Composite Vascular Graft (FDA Code: MAL / 870.3450) |
• Temporary Carotid Catheter For Embolic Capture (FDA Code: NTE / 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. |
• Temporary Coronary Saphenous Vein Bypass Graft For Embolic Protection (FDA Code: NFA / 870.1250) |
• Temporary Intravascular Occluding Catheter (FDA Code: MJN / 870.4450) A vascular clamp is a surgical instrument used to occlude a blood vessel temporarily. |
• 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. |
• Thrombectomy Devices, Infusion Catheter |
• Tip Angiographic Catheters |
• Titanium Cardiovascular Clamps |
• Titanium Needle Holders |
• Totally Implanted Spinal Cord Stimulator for Pain Relief (FDA Code: LGW) |
• Transtracheal Catheters |
• Transurethral Needle Ablation Therapy |
• Transvaginal Anchor System |
• Triangle Needle Holder |
• Tungsten Carbide Needle Holders |
• Tunneled Catheter |
• Ultrasonic Imaging Catheter |
• Ultrasonic Puls-Echo Scanner (FDA Code: IYO / 892.1560) An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories. |
• Ultrasonic Pulsed Doppler Imaging System (FDA Code: IYN / 892.1550) An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories. |