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U.S. Department of Health and Human Services

Establishment Registration & Device Listing

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Proprietary Name: Flextome Cutting Balloon Monorail; Flextome Cutting Balloon Over-The-Wire
Classification Name: CATHETER, PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA), CUTTING/SCORING
Product Code: NWX
Device Class: 3
Registered Establishment Name: Boston Scientific Limited
Registered Establishment Number: 9681260
Owner/Operator: Boston Scientific Corporation
Owner/Operator Number: 9912058
Establishment Operations: Manufacturer
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