Biosense Webster, Inc.
FDA 510(k) & PMA Approved Devices — 33 products
Total Devices33
Categories9
Latest FDA decision2026-07-01
| Type | Number | Device Name | Code | Date | Actions |
|---|---|---|---|---|---|
| 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 |
| 510(k) | K193632 | LassoStar Circular Mapping Catheter | DRF | 2020-06-30 | View |
| 510(k) | K191660 | CARTO 3 EP Navigation System, Version 7.1 and Accessories | DQK | 2019-07-20 | View |
| 510(k) | K173978 | CARTO 3 EP Navigation System, Version 5.2 and Accessories with CARTOFINDER Module | DQK | 2018-08-24 | View |
| 510(k) | K173977 | CARTO 3 EP Navigation System, Version 4.35 and Accessories with COHERENT MAP Module | DQK | 2018-06-14 | View |
| 510(k) | K180238 | CARTO 3 EP Navigation System, Version 6.0 and Accessories with VISITAG SURPOINT | DQK | 2018-06-01 | View |
| 510(k) | K170997 | CARTO VIZIGO 8.5F Bi-Directional Guiding Sheath | DYB | 2017-07-25 | View |
| 510(k) | K170600 | CARTO 3 EP Navigation System, Version 6.0 and Accessories | DQK | 2017-07-25 | View |
No matching devices.
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Related Clinical Trials
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