• 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: Celsius RMT ThermoCool Catheter; Celsius ThermoCool Catheter; EZ Steer ThermoCool Catheter; EZ Steer ThermoCool NAV Catheter; NaviStar RMT ThermoCool Catheter; NAVISTAR THERMOCOOL CATHETER; ThermoCool SF Bi-Directional Catheter; ThermoCool SF Catheter; ThermoCool SF NAV Bi-Directional Catheter; ThermoCool SF NAV Catheter
Classification Name: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION
Product Code: OAE
Device Class: 3
Registered Establishment Name: BIOSENSE WEBSTER, INC.
Registered Establishment Number: 9673241
Owner/Operator: BIOSENSE WEBSTER, INC.
Owner/Operator Number: 9044811
Establishment Operations: Manufacturer
-
-