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Biosense Webster, Inc.

FDA 510(k) & PMA Approved Devices — 33 products

Total Devices33
Categories9
Latest FDA decision2026-07-01
TypeNumberDevice NameCodeDateActions
PMA P030031 catheter, percutaneous, cardiac ablation, for treatment of atrial flutterOAD2026-07-01 View
PMA P240006 Percutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with Irreversible ElectroporationQZI2026-06-30 View
PMA P210027 Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillationOAE2026-04-17 View
510(k) K252972 CARTO™ 3 EP Navigation System V8.4DQK2026-02-20 View
510(k) K254085 CARTO™ 3 EP Navigation System V9.0 with PIU PlusDQK2026-01-18 View
PMA P990071 Cardiac ablation percutaneous catheterLPB2025-12-23 View
510(k) K252302 CARTO™ 3 EP Navigation System V8.1DQK2025-08-22 View
PMA P010068 catheter, percutaneous, cardiac ablation, for treatment of atrial flutterOAD2025-02-26 View
PMA P950005 Cardiac ablation percutaneous catheterLPB2025-02-26 View
PMA P990025 CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDINGDRF2025-02-25 View
PMA P040036 Cardiac ablation percutaneous catheterLPB2025-02-25 View
510(k) K241540 NUVISION™ Ultrasound Catheter; NUVISION™ NAV Ultrasound CatheterOBJ2024-06-28 View
510(k) K240050 SOUNDSTAR™ CRYSTAL Ultrasound CatheterOBJ2024-06-12 View
510(k) K231207 CARTO™ 3 EP Navigation System Software V8.0 (FG-5400-00, FG-5400-00U)DQK2023-09-07 View
510(k) K231412 CARTO VIZIGO® 8.5F Bi-Directional Guiding Sheath (D-1385-01-S, D-1385-02-S, D-1385-03-S)DYB2023-07-10 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 IDMTD2023-07-10 View
510(k) K230253 OPTRELL™ Mapping Catheter with TRUEref™ TechnologyMTD2023-03-02 View
510(k) K223766 NUVISION™ NAV Ultrasound CatheterOBJ2023-02-16 View
510(k) K223733 CARTO® 3 EP Navigation System with CARTOSOUND™ 4D Version 7.4DQK2023-02-16 View
510(k) K221112 CARTO 3 EP Navigation System with Advanced Focus Mapping (AFM)DQK2022-08-17 View

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Related Clinical Trials

NCT02565069Identification for the Treatment of Complex ArrhythmiasCOMPLETEDNCT04750798An Observational Post-marketing Study Using Commercially Approved Biosense Webster (BWI) Medical Devices for the Treatment of Participants With Cardiac ArrhythmiasRECRUITINGNCT05565599An Early Feasibility Study Evaluating the Safety and Efficacy of the Laminar Left Atrial Appendage Closure System in Subjects With Non-Valvular Atrial FibrillationACTIVE_NOT_RECRUITINGNCT06168942A Pivotal Investigational Device Exemption Study on Laminar Left Atrial Appendage EliminationSUSPENDEDNCT07116525A Study Assessing Arrhythmia Mapping With a Multi-Electrode Mapping CatheterRECRUITINGNCT07227532A Study Assessing Long-Term Safety and Effectiveness in Treatment Management of Atrial Fibrillation With VARIPULSE Catheter SystemRECRUITINGNCT07428564A Study of VARIPULSE Catheter and TRUPULSE Generator With VARIPULSE PRO Software in Participants With PsAFRECRUITINGNCT07429214A Study of VARIPULSE Catheter and TRUPULSE Generator With VARIPULSE Pro Software in Participants With PAF or PsAFRECRUITINGNCT07523750A Study of VARIPULSE Pulsed Field Ablation (PFA) Catheter and FARAWAVE PFA Catheter in the Treatment of Participants With Persistent Atrial FibrillationRECRUITINGNCT07527299A Study of VARIPULSE Catheter in Participants With Persistent Atrial Fibrillation Undergoing Pulmonary Vein and Superior Vena Cava IsolationRECRUITING
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