• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Establishment Registration & Device Listing

  • Print
  • Share
  • E-mail
New Search Back To Search Results
Proprietary Name: Rotablator Dynaglide Foot Pedal; Rotablator Rotational Atherectomy System; RotaGlide Lubricant; RotaLink Advancer Catheter Advancing Device; RotaLink Burr Exchangeable Burr Catheter; RotaLink Plus Pre-Connected Exchangeable Burr Catheter and Burr Advancing Device; Rotational Atherectomy System Console with Dynaglide Foot Pedal; RotaWire and wireClip Torquer EXTRA SUPPORT Guidewire and Guidewire Manipulation Device; RotaWire and wireClip Torquer FLOPPY Guidewire and Guidewire Manipulation Device
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