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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• Ablation Catheter

• Active Fixation Steroid Eluting

• Alligator Jaw-step Biopsy Forceps

• Angiographic Catheter

• Angiographic Catheter Amplatz Left 1.0

• Angiographic Catheter, Angled Pigtail

• Angiographic Catheter, El Gamal Multipurpose

• Angiographic Catheter, El Gamal Sones

• Angiographic Catheter, Multipurpose El Gamal Curve

• Angiographic Catheter, Pigtail Diagnostic Catheters

• Angiographic Injector and Syringe (FDA Code: DXT / 870.1650) An angiographic injector and syringe is a device that consists of a syringe and a high-pressure injector which are used to inject contrast material into the heart, great vessels, and coronary arteries to study the heart and vessels by x-ray photography.

• Angiographic Wire Guide

• Angiography Equipment

• Angiography Equipment & Systems

• Angiography Equipment & Systems Accessories

• Angioplasty Guidewire

• Aortic Stent Systems

• Arterial Catheters

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

• Atherectomy Coronary Catheter (FDA Code: MCX)

• Atherectomy Peripheral Catheter (FDA Code: MCW / 870.4875) An intraluminal artery stripper is a device used to perform an endarterectomy (removal of plaque deposits from arterisclerotic arteries.)

• Automatic Implantable Cardioverter-defibrillator (FDA Code: LWS)

• Balloon Inflation Syringe (FDA Code: MAV / 870.1650)

• Balloon Type Cardiovascular Catheter

• Balloon Type Catheter (FDA Code: GBA / 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.

• Beating Heart Surgery System

• Biliary & Pancreatic Procedures, Biopsy Forceps

• Biliary Mechanical Lithotriptor (FDA Code: LQC / 876.4500) A mechanical lithotriptor is a device with steel jaws that is inserted into the urinary bladder through the urethra to grasp and crush bladder stones.

• Biliary Stent Systems

• Biliary Stone Dislodger (FDA Code: LQR / 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.

• Biliary Stone Retrieval Basket

• Biological Vascular Graft

• Biopsy Forceps

• Biopsy Forceps Excision

• Biopsy Forceps Femoral Approach

• Biopsy Forceps with Rotating Shafts

• Biopsy Forceps with Two Teeth

• Biopsy Forceps, Internal Jugular Approach

• Biopsy Forceps, Internal Jugular Approach 7

• Biopsy Instruments (FDA Code: KNW / 876.1075) A gastroenterology-urology biopsy instrument is a device used to remove, by cutting or aspiration, a specimen of tissue for microscopic examination. This generic type of device includes the biopsy punch, gastrointestinal mechanical biopsy instrument, suction biopsy instrument, gastro-urology biopsy needle and needle set, and nonelectric biopsy forceps. This section does not apply to biopsy instruments that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.

• Biopsy Instruments (FDA Code: KNW / 876.1075)

• Biopsy Needle Kit (FDA Code: FCG / 876.1075)

• Bipolar Ventricular Lead

• Blood Collection Sets with Needle Holder

• Blood Needle Holder Systems

• Bone Fixation Screw (FDA Code: HWC / 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.

• Bronchoscope Accessories (FDA Code: KTI / 874.4680) A bronchoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the bronchoscope and is intended to examine or treat the larynx and tracheobronchial tree. It is typically used with a fiberoptic light source and carrier to provide illumination. The device is made of materials such as stainless steel or flexible plastic. This generic type of device includes the rigid ventilating bronchoscope, rigid nonventilating bronchoscope, nonrigid bronchoscope, laryngeal-bronchial telescope, flexible foreign body claw, bronchoscope tubing, flexible biopsy forceps, rigid biopsy curette, flexible biopsy brush, rigid biopsy forceps, flexible biopsy curette, and rigid bronchoscope aspirating tube, but excludes the fiberoptic light source and carrier.

• Capillary Adapter Cleaning Kit

• Cardiac Ablation Percutaneous Catheter (FDA Code: LPB)

• Cardiac Ablation Percutaneous Catheter For Treatment Of Atrial Flutter (FDA Code: OAD)