Biosense Webster, Inc.
FDA 510(k) & PMA Approved Devices — 33 products
Total Devices33
Categories9
Latest Approval2026-02-20
| Type | Number | Device Name | Code | Date | |
|---|---|---|---|---|---|
| 510(k) | K252972 | CARTO 3 EP Navigation System V8.4 | DQK | 2026-02-20 | View |
| 510(k) | K254085 | CARTO 3 EP Navigation System V9.0 with PIU Plus | DQK | 2026-01-18 | View |
| 510(k) | K252302 | CARTO 3 EP Navigation System V8.1 | DQK | 2025-08-22 | View |
| PMA | P240006 | Percutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with Irreversible Electroporation | QZI | 2024-11-06 | View |
| 510(k) | K241540 | NUVISION Ultrasound Catheter; NUVISION NAV Ultrasound Catheter | OBJ | 2024-06-28 | View |
| 510(k) | K240050 | SOUNDSTAR CRYSTAL Ultrasound Catheter | OBJ | 2024-06-12 | View |
| 510(k) | K231207 | CARTO 3 EP Navigation System Software V8.0 (FG-5400-00, FG-5400-00U) | DQK | 2023-09-07 | View |
| 510(k) | K231412 | CARTO VIZIGO® 8.5F Bi-Directional Guiding Sheath (D-1385-01-S, D-1385-02-S, D-1385-03-S) | DYB | 2023-07-10 | View |
| 510(k) | K231312 | 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 ID | MTD | 2023-07-10 | View |
| 510(k) | K230253 | OPTRELL Mapping Catheter with TRUEref Technology | MTD | 2023-03-02 | View |
| 510(k) | K223766 | NUVISION NAV Ultrasound Catheter | OBJ | 2023-02-16 | View |
| 510(k) | K223733 | CARTO® 3 EP Navigation System with CARTOSOUND 4D Version 7.4 | DQK | 2023-02-16 | View |
| PMA | P210027 | Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation | OAE | 2022-11-23 | View |
| 510(k) | K221112 | CARTO 3 EP Navigation System with Advanced Focus Mapping (AFM) | DQK | 2022-08-17 | View |
| 510(k) | K211438 | OPTRELL Mapping Catheter with TRUEref Technology | MTD | 2022-03-18 | View |
| 510(k) | K211219 | LASSOSTAR NAV Circular Mapping Catheter | DRF | 2022-01-26 | View |
| 510(k) | K213264 | CARTO 3 EP Navigation System Version 7.2 | DQK | 2021-10-29 | View |
| 510(k) | K200484 | CARTO® 3 EP Navigation System with Signal Processing Unit | DQK | 2020-11-25 | View |
| 510(k) | K201750 | Pentaray Nav eco High-Density Mapping Catheter | MTD | 2020-08-06 | View |
| 510(k) | K193237 | Carto Octaray Mapping Catheter with Trueref Technology | MTD | 2020-07-31 | View |
No matching devices.
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