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U.S. Department of Health and Human Services

Establishment Registration & Device Listing
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Proprietary Name: EZ Steer ThermoCool NAV Catheter; NaviStar RMT ThermoCool Catheter; NaviStar ThermoCool Catheter; ThermoCool SF NAV Bi-Directional Catheter; ThermoCool SF NAV CAtheter
Classification Name: CARDIAC ABLATION PERCUTANEOUS CATHETER
Product Code: LPB
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
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