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Biosense Webster, Inc. FDA Approvals
0 new drug approvals and 15 device clearances on file. This applicant is not matched to a listed company.
Newest first
A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.
| Product |
|---|
| CARTO 3 EP Navigation System V8.4510(k)Feb 20, 2026Cardiovascular |
| CARTO 3 EP Navigation System V9.0 with PIU Plus510(k)Jan 18, 2026Cardiovascular |
| CARTO 3 EP Navigation System V8.1510(k)Aug 22, 2025Cardiovascular |
| NUVISION Ultrasound Catheter; NUVISION NAV Ultrasound Catheter510(k)Jun 28, 2024Cardiovascular |
| SOUNDSTAR CRYSTAL Ultrasound Catheter510(k)Jun 12, 2024Cardiovascular |
| CARTO 3 EP Navigation System Software V8.0 (FG-5400-00, FG-5400-00U)510(k)Sep 7, 2023Cardiovascular |
| PENTARAY® NAV ECO High Density Mapping Catheter, DECANAV® Mapping Catheter, Webster® CS Catheter with Auto ID, Webster® CS Catheter with EZ Steer Technology, Webster® CS Catheter with EZ Steer Technology with Auto ID510(k)Jul 10, 2023Cardiovascular |
| CARTO VIZIGO® 8.5F Bi-Directional Guiding Sheath (D-1385-01-S, D-1385-02-S, D-1385-03-S)510(k)Jul 10, 2023Cardiovascular |
| OPTRELL Mapping Catheter with TRUEref Technology510(k)Mar 2, 2023Cardiovascular |
| CARTO® 3 EP Navigation System with CARTOSOUND 4D Version 7.4510(k)Feb 16, 2023Cardiovascular |
| NUVISION NAV Ultrasound Catheter510(k)Feb 16, 2023Cardiovascular |
| CARTO 3 EP Navigation System with Advanced Focus Mapping (AFM)510(k)Aug 17, 2022Cardiovascular |
| OPTRELL Mapping Catheter with TRUEref Technology510(k)Mar 18, 2022Cardiovascular |
| LASSOSTAR NAV Circular Mapping Catheter510(k)Jan 26, 2022Cardiovascular |
| CARTO 3 EP Navigation System Version 7.2510(k)Oct 29, 2021Cardiovascular |