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U.S. Department of Health and Human Services

Establishment Registration & Device Listing

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Proprietary Name: 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
Classification Name: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
Product Code: LOX
Device Class: 2
Regulation Number: 870.5100
Medical Specialty: Cardiovascular
Registered Establishment Name: BOSTON SCIENTIFIC CORPORATION
Registered Establishment Number: 2134265
Owner/Operator: Boston Scientific Corporation
Owner/Operator Number: 9912058
Establishment Operations: Manufacturer
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