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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• Umbilical Artery Catheter (FDA Code: FOS / 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.

• Universal Y Adapter w/flushing Port

• Ureteral Catheter Adapter (FDA Code: EYI / 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).

• Ureteral Catheter Connector (FDA Code: EYK / 876.5130)

• Ureteral Catheter Dilator (FDA Code: EZN / 876.5470) A ureteral dilator is a device that consists of a specially shaped catheter or bougie and is used to dilate the ureter at the place where a stone has become lodged or to dilate a ureteral stricture.

• Ureteral Splint (FDA Code: FAD / 876.4620) A ureteral stent is a tube-like implanted device that is inserted into the ureter to provide ureteral rigidity and allow the passage of urine. The device may have finger-like protrusions or hooked ends to keep the tube in place. It is used in the treatment of ureteral injuries and ureteral obstruction.

• Ureteroscopic Biopsy Forceps

• Urethral Access Sheaths

• Urethral Catheters (FDA Code: GBM / 876.5130)

• Urethral Dilators (FDA Code: KOE / 876.5520) A urethral dilator is a device that consists of a slender hollow or solid instrument made of metal, plastic, or other suitable material in a cylindrical form and in a range of sizes and flexibilities. The device may include a mechanism to expand the portion of the device in the urethra and indicate the degree of expansion on a dial. It is used to dilate the urethra. This generic type of device includes the mechanical urethral dilator, urological bougies, metal or plastic urethral sound, urethrometer, filiform, and filiform follower.

• Urethral Diversion Stents

• Urethral Stents, Endoureterotomy Stents

• Urinary Catheterization Kit

• Urological Catheters (FDA Code: KOD / 876.5130)

• Urological Male External Catheters

• Urological Percutaneous Catheters and Sets

• Uterine Biopsy Forceps

• Vaginal Retractors (FDA Code: HDL / 884.4520) An obstetric-gynecologic general manual instrument is one of a group of devices used to perform simple obstetric and gynecologic manipulative functions. This generic type of device consists of the following:

• Vascular Access Graft (FDA Code: LTH)

• Vascular Clamps (FDA Code: DXC / 870.4450) A vascular clamp is a surgical instrument used to occlude a blood vessel temporarily.

• Vascular Device for Promoting Embolization (FDA Code: KRD / 870.3300)

• Vascular Graft Prosthesis (FDA Code: DSY / 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.

• Vascular Needle Holder

• Vena Cava Filters

• ventricular tachyarrhythmia therapy Device

• Vertical Needle Holder

• Vessel Dilatation Balloon Catheter

• Water Jet Lavage Unit (FDA Code: FQH / 880.5475) A jet lavage is a device used to clean a wound by a pulsatile jet of sterile fluid. The device consists of the pulsing head, tubing to connect to a container of sterile fluid, and a means of propelling the fluid through the tubing, such as an electric roller pump.

• Whistle Tip Urethral Catheter

• Y Adapter (FDA Code: FJP / 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.