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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: STENT, RENAL
Product Code: NIN
Device Class: 3
Registered Establishment Name: BOSTON SCIENTIFIC CORPORATION
Registered Establishment Number: 2134265
Owner/Operator: Boston Scientific Corporation
Owner/Operator Number: 9912058
Establishment Operations: Specification Developer