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U.S. Department of Health and Human Services

Establishment Registration & Device Listing
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Classification Name: CATHETER, PERIPHERAL, ATHERECTOMY
Product Code: MCW
Device Class: 2
Regulation Number: 870.4875
Medical Specialty: Cardiovascular
Registered Establishment Name: Boston Scientific Limited
Registered Establishment Number: 9616684
Premarket Submission Number: K121774
Owner/Operator: Boston Scientific Corporation
Owner/Operator Number: 9912058
Establishment Operations: Manufacturer
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