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U.S. Department of Health and Human Services

Establishment Registration & Device Listing

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Proprietary Name: Peripheral RotaLink Plus Pre-Connected Exchange Burr Catheter and Burr Advancing Device; Peripheral RotaWire and wireClip Torquer EXTRA SOFT Guidewire and Guidewire Manipulation Device; Peripheral RotaWire and wireClip Torquer FLOPPY Guidewire and Guidewire Manipulation Device; Rotablator Dynaglide Foot Pedal; Rotablator Rotational Atherectomy System; RotaGlide Lubricant
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
Owner/Operator: Boston Scientific Corporation
Owner/Operator Number: 9912058
Establishment Operations: Manufacturer
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