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U.S. Department of Health and Human Services

Establishment Registration & Device Listing

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Proprietary Name: Extra Support Guidewire and Guidewire Manipulation Device; Floppy Guidewire and Guidewire Manipulation Device; Pre-Connected Exchangeable Burr Catheter and Burr Advancing Device; Rotablator Rotational Atherectomy System; RotaLink Advancer Catheter Advancing Device; RotaLink Burr Exchangeable Burr Catheter; RotaLink Plus; Rotational Atherectomy System Console with Dynaglide Foot Pedal; RotaWire and wireClip Torquer
Classification Name: CATHETER, CORONARY, ATHERECTOMY
Product Code: MCX
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
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