Establishment Registration & Device Listing

Establishment Registration Number : 2134265 Product Code : LOX

Establishment Name	Registration Number	Current Registration Yr
BOSTON SCIENTIFIC CORPORATION MN/USA	2134265	2013
catheters, transluminal coronary angioplasty, percutaneous - Flextome Cutting Balloon Monorail; Flextome Cutting Balloon Over-The-Wire		Specification Developer
catheters, transluminal coronary angioplasty, percutaneous - Apex Flex Monorail PTCA Dilatation Catheter; Apex Flex Over-the-Wire Monorail PTCA Dilatation Catheter; Apex Monorail PTCA Dilatation Catheter; Apex Over-the-Wire PTCA Dilatation Catheter; Apex Push Monorail PTCA Dilatation Catheter; Apex Push Over-the-Wire Monorail PTCA Dilatation Catheter; Maverick 2 Monorail PTCA Dilatation Catheter; Maverick Over-the-Wire PTCA Dilatation Catheter; Maverick XL Monorail PTCA Dilatation Catheter; NC Quantum Apex Monorail PTCA Dilatation Catheter; NC Quantum Apex Over-the-Wire PTCA Dilatation Catheter; Quantum Maverick Monorail PTCA Dilatation Catheter; Quantum Maverick Over-the-Wire PTCA Dilatation Catheter		Manufacturer
catheters, transluminal coronary angioplasty, percutaneous - Emerge Monorail PTCA Dilatation Catheter; Emerge Over-The-Wire PTCA Dilatation Catheter; Emerge Push Monorail PTCA Dilatation Catheter; Emerge Push Over-The-Wire PTCA Dilatation Catheter; Gateway Monorail		U.S. Manufacturer of Export Only Devices
catheters, transluminal coronary angioplasty, percutaneous - Emerge Monorail PTCA Dilatation Catheter; Emerge Over-The-Wire PTCA Dilatation Catheter		Manufacturer
catheters, transluminal coronary angioplasty, percutaneous - Emerge Monorail PTCA Dilatation Catheter; Emerge Over-The-Wire PTCA Dilatation Catheter; Emerge Push Monorail PTCA Dilatation Catheter; Emerge Push Over-The-Wire PTCA Dilatation Catheter		Manufacturer
catheters, transluminal coronary angioplasty, percutaneous - NC Quantum Apex Monorail PTCA Dilatation Catheter		Manufacturer

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