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U.S. Department of Health and Human Services

Establishment Registration & Device Listing

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Proprietary Name: Guidewire and Guidewire Manipulation Device; Peripheral RotaLink Plus; Peripheral RotaWire Guidewire and wireClip Torquer; Pre-Connected Exchange Burr Catheter and Burr Advancing Device; Rotablator; Rotaglide Lubricant; Rotational Atherectomy System; Rotational Atherectomy System Console with Dynaglide Foot Pedal
Classification Name: CATHETER, PERIPHERAL, ATHERECTOMY
Product Code: MCW
Device Class: 2
Regulation Number: 870.4875
Medical Specialty: Cardiovascular
Registered Establishment Name: BOSTON SCIENTIFIC CORPORATION
Registered Establishment Number: 2134265
Owner/Operator: Boston Scientific Corporation
Owner/Operator Number: 9912058
Establishment Operations: Specification Developer
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