Data / Medical devices / United States / Biosense Webster, Inc.
Biosense Webster, Inc.: FDA-registered device maker in Irvine, CA, United States, 65 510(k) clearances and 8 PMA approvals
Biosense Webster, Inc. is registered with the FDA (registration 3013300026) in Irvine, CA, United States. It lists 11 device types. The FDA files 65 510(k) clearances and 8 PMA approvals under its listings, the newest dated February 20, 2026. 4 recall events name it as the recalling firm (1 Class I). Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3013300026
- Address
- 31 Technology Drive, Suite 200 --, Irvine, CA, United States, 92618
- Owner or operator
- BIOSENSE WEBSTER, INC. (9044811)
- Roles
- Complaint file establishment, Manufacturer, Specification developer
- First device listed
- November 28, 2006
- Registered through
- 2027
- Brand names listed
- Biosense Webster LASSO Deflectable Mapping Catheter, Biosense Webster Patient Cable and Leadwires, CARTO 3 EP NAVIGATION SYSTEM, V1 AND ACCESSORIES, CARTO 3 EP Navigation System & CARTO 3 External Reference Patches, CARTO 3 EP Navigation System V8.4, CARTO 3 EP Navigation System Version 7.2, CARTO 3 EP Navigation System with Advanced Focus Mapping (AFM), CARTO 3 EP Navigation System with CARTOSOUND 4D v7/4 and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| February 20, 2026 | K252972 | CARTO 3 EP Navigation System V8.4 | DQK | Substantially Equivalent | Biosense Webster, Inc. | accessdata.fda.gov |
| January 18, 2026 | K254085 | CARTO 3 EP Navigation System V9.0 with PIU Plus | DQK | Substantially Equivalent | Biosense Webster, Inc. | accessdata.fda.gov |
| August 22, 2025 | K252302 | CARTO 3 EP Navigation System V8.1 | DQK | Substantially Equivalent | Biosense Webster, Inc. | accessdata.fda.gov |
| June 28, 2024 | K241540 | NUVISION Ultrasound Catheter; NUVISION NAV Ultrasound Catheter | OBJ | Substantially Equivalent | Biosense Webster, Inc. | accessdata.fda.gov |
| June 12, 2024 | K240050 | SOUNDSTAR CRYSTAL Ultrasound Catheter | OBJ | Substantially Equivalent | Biosense Webster, Inc. | accessdata.fda.gov |
| September 7, 2023 | K231207 | CARTO 3 EP Navigation System Software V8.0 (FG-5400-00, FG-5400-00U) | DQK | Substantially Equivalent | Biosense Webster, Inc. | accessdata.fda.gov |
| July 10, 2023 | 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 | Substantially Equivalent | Biosense Webster, Inc. | accessdata.fda.gov |
| March 2, 2023 | K230253 | OPTRELL Mapping Catheter with TRUEref Technology | MTD | Substantially Equivalent | Biosense Webster, Inc. | accessdata.fda.gov |
| February 16, 2023 | K223766 | NUVISION NAV Ultrasound Catheter | OBJ | Substantially Equivalent | Biosense Webster, Inc. | accessdata.fda.gov |
| February 16, 2023 | K223733 | CARTO® 3 EP Navigation System with CARTOSOUND 4D Version 7.4 | DQK | Substantially Equivalent | Biosense Webster, Inc. | accessdata.fda.gov |
| August 17, 2022 | K221112 | CARTO 3 EP Navigation System with Advanced Focus Mapping (AFM) | DQK | Substantially Equivalent | Biosense Webster, Inc. | accessdata.fda.gov |
| March 18, 2022 | K211438 | OPTRELL Mapping Catheter with TRUEref Technology | MTD | Substantially Equivalent | Biosense Webster, Inc. | accessdata.fda.gov |
| January 26, 2022 | K211219 | LASSOSTAR NAV Circular Mapping Catheter | DRF | Substantially Equivalent | Biosense Webster, Inc. | accessdata.fda.gov |
| October 29, 2021 | K213264 | CARTO 3 EP Navigation System Version 7.2 | DQK | Substantially Equivalent | Biosense Webster, Inc. | accessdata.fda.gov |
| March 5, 2021 | K201775 | NuVision ICE Catheter | OBJ | Substantially Equivalent | Nuvera Medical, Inc. | accessdata.fda.gov |
| November 25, 2020 | K200484 | CARTO® 3 EP Navigation System with Signal Processing Unit | DQK | Substantially Equivalent | Biosense Webster, Inc. | accessdata.fda.gov |
| August 6, 2020 | K201750 | Pentaray Nav eco High-Density Mapping Catheter | MTD | Substantially Equivalent | Biosense Webster, Inc. | accessdata.fda.gov |
| July 31, 2020 | K193237 | Carto Octaray Mapping Catheter with Trueref Technology | MTD | Substantially Equivalent | Biosense Webster, Inc. | accessdata.fda.gov |
| June 30, 2020 | K193632 | LassoStar Circular Mapping Catheter | DRF | Substantially Equivalent | Biosense Webster, Inc. | accessdata.fda.gov |
| July 20, 2019 | K191660 | CARTO 3 EP Navigation System, Version 7.1 and Accessories | DQK | Substantially Equivalent | Biosense Webster, Inc. | accessdata.fda.gov |
| August 24, 2018 | K173978 | CARTO 3 EP Navigation System, Version 5.2 and Accessories with CARTOFINDER Module | DQK | Substantially Equivalent | Biosense Webster, Inc. | accessdata.fda.gov |
| June 14, 2018 | K173977 | CARTO 3 EP Navigation System, Version 4.35 and Accessories with COHERENT MAP Module | DQK | Substantially Equivalent | Biosense Webster, Inc. | accessdata.fda.gov |
| June 1, 2018 | K180238 | CARTO 3 EP Navigation System, Version 6.0 and Accessories with VISITAG SURPOINT | DQK | Substantially Equivalent | Biosense Webster, Inc. | accessdata.fda.gov |
| July 25, 2017 | K170997 | CARTO VIZIGO 8.5F Bi-Directional Guiding Sheath | DYB | Substantially Equivalent | Biosense Webster, Inc. | accessdata.fda.gov |
| July 25, 2017 | K170600 | CARTO 3 EP Navigation System, Version 6.0 and Accessories | DQK | Substantially Equivalent | Biosense Webster, Inc. | accessdata.fda.gov |
| March 12, 2014 | K140318 | SOUNDSTAR ECO 8F GULTRASOUND CATHETER, SOUNDSTAR ECO 8F ULTRASOUND CATHETER | OBJ | Substantially Equivalent | Biosense Webster | accessdata.fda.gov |
| August 14, 2013 | K130602 | LASSO NAV DUO LOOP CATHETER | DRF | Substantially Equivalent | Biosense Webster, Inc. | accessdata.fda.gov |
| March 5, 2013 | K123837 | PENTARAY NAV ECO HIGH-DENSITY MAPPING CATHETER | MTD | Substantially Equivalent | Biosense Webster, Inc. | accessdata.fda.gov |
| May 24, 2012 | K120425 | PENTARAY NAV HIGH-DENSITY MAPPING CATHETER | MTD | Substantially Equivalent | Biosense Webster, Inc. | accessdata.fda.gov |
| December 5, 2011 | K113213 | LASSO 2515 NAV ECO VARIABLE CATHETER LASSO NAV ECO CATHETER CONTINUED FROM LINE 2 | DRF | Substantially Equivalent | Biosense Webster, Inc. | accessdata.fda.gov |
| November 18, 2011 | K112050 | SOUNDSTAR ECO DIAGNOSTIC ULTRASOUND CATHETER | OBJ | Substantially Equivalent | Biosense Webster, Inc. | accessdata.fda.gov |
| May 2, 2011 | K101991 | WEBSTER DUO-DECAPOLAR CATHETER | DRF | Substantially Equivalent | Biosense Webster, Inc. | accessdata.fda.gov |
| June 22, 2010 | K101345 | WEBSTER CS CATHETER WITH EZ STEER TECHNOLOGY, WEBSTER CS CATHETER WITH EZ STEER TECHNOLOGY AND AUTO ID MODEL: D-1263-04, | DRF | Substantially Equivalent | Biosense Webster, Inc. | accessdata.fda.gov |
| June 22, 2010 | K101138 | SOUNDSTAR 3D ULTRASOUND CATHETER MODEL M-5723-12 | OBJ | Substantially Equivalent | Biosense Webster, Inc. | accessdata.fda.gov |
| June 18, 2010 | K093376 | LASSO NAV CATHETER | DRF | Substantially Equivalent | Biosense Webster, Inc. | accessdata.fda.gov |
| December 4, 2009 | K091352 | SOUNDSTAR 3D DIAGNOSTIC CATHETER, MODEL M-5723-05 | OBJ | Substantially Equivalent | Biosense Webster, Inc. | accessdata.fda.gov |
| October 13, 2009 | K090017 | CARTO 3 EP NAVIGATION SYSTEM, V1.0 AND ACCESSORIES | DQK | Substantially Equivalent | Biosense Webster, Inc. | accessdata.fda.gov |
| September 4, 2009 | K090898 | CORONARY SINUS DEFLECTABLE MAPPING CATHETER, MODEL D-1263-01, WEBSTER CS CATHETER WITH EZ STEER | DRF | Substantially Equivalent | Biosense Webster, Inc. | accessdata.fda.gov |
| August 7, 2009 | K092064 | SOUNDSTAR 3D ULTRASOUND CATHETER, MODEL M-5723-12 | OBJ | Substantially Equivalent | Biosense Webster, Inc. | accessdata.fda.gov |
| March 24, 2009 | K090120 | REFSTAR PLUS WITH QWIKPATCH EXTERNAL REFERENCE PATCH, MODEL D-1210-03, REFSTAR PLUS CABLE, MODEL M-4700-106 | DRF | Substantially Equivalent | Biosense Webster, Inc. | accessdata.fda.gov |
| January 6, 2009 | K081258 | VARIABLE LASSO NAV CATHETER, MODELS: D-1290-01, D-1290-02 | DRF | Substantially Equivalent | Biosense Webster, Inc. | accessdata.fda.gov |
| April 23, 2008 | K080425 | CS REFSTAR CATHETER (D- AND F-CURVES), MODELS D-1285-01 AND D-1285-02 | DRF | Substantially Equivalent | Biosense Webster, Inc. | accessdata.fda.gov |
| November 19, 2007 | K072202 | CARTO 3 NAVIGATION SYSTEM (MODEL:FG-5400-00), CARTO 3 EXTERNAL REFERENCE PATCHES (MODEL:D-1283-01) | DQK | Substantially Equivalent | Biosense Webster, Inc. | accessdata.fda.gov |
| May 15, 2007 | K070242 | SOUNDSTAR 3D ULTRASOUND CATHETER, MODEL M-5723-05 | OBJ | Substantially Equivalent | Biosense Webster, Inc. | accessdata.fda.gov |
| August 14, 2006 | K061468 | REFSTAR EXTERNAL REFERENCE PATCH | DRF | Substantially Equivalent | Biosense Webster, Inc. | accessdata.fda.gov |
| August 14, 2006 | K061463 | ESOPHAGEAL MAPPING CATHETER, MODEL D-1272-01-S | DRF | Substantially Equivalent | Biosense Webster, Inc. | accessdata.fda.gov |
| September 29, 2005 | K052083 | NAVISTAR RMT STEERABLE TIP DIAGNOSTIC CATHETER | DRF | Substantially Equivalent | Biosense Webster, Inc. | accessdata.fda.gov |
| September 29, 2005 | K042998 | REFSTAR RMT EXTERNAL REFERENCE PATCH | DRF | Substantially Equivalent | Biosense Webster, Inc. | accessdata.fda.gov |
| June 24, 2005 | K050877 | CORONARY SINUS DEFLECTABLE MAPPING CATHETER, 4 FR, 5 FR, 6 FR & 7 FR | DRF | Substantially Equivalent | Biosense Webster, Inc. | accessdata.fda.gov |
| March 30, 2005 | K050217 | FLOWER HIGH-DENSITY MAPPING CATHETER, 4-4-4 MM ELECTRODE SPACING), (2-6-2 MM ELECTRODE SPACING) | MTD | Substantially Equivalent | Biosense Webster, Inc. | accessdata.fda.gov |
| July 22, 2003 | K031161 | VARIABLE LASSO 2515 CIRCULAR MAPPING CATHETER | DRF | Substantially Equivalent | Biosense Webster, Inc. | accessdata.fda.gov |
| August 31, 2000 | K002333 | BIOSENSE WEBSTER LASSO DEFLECTABLE CIRCULAR MAPPING CATHETER, MODEL D-1220 | DRF | Substantially Equivalent | Biosense Webster, Inc. | accessdata.fda.gov |
| July 21, 2000 | K001390 | BIOSENSE WEBSTER PATIENT CABLE AND LEADWIRES | DSA | Substantially Equivalent | Biosense Webster, Inc. | accessdata.fda.gov |
| May 10, 2000 | K001139 | PREFACE GUIDING SHEATH, MODELS 2-603M, 2-703M, 2-803M, 2-903M, 2-1003M, 2-1103M | DYB | Substantially Equivalent | Biosense Webster, Inc. | accessdata.fda.gov |
| November 26, 1999 | K992965 | CORDIS WEBSTER FIXED CURVE CATHETERS, MODELS D-1124, D-1085 | DRF | Substantially Equivalent | Cordis Webster, Inc. | accessdata.fda.gov |
| October 4, 1999 | K991531 | CORDIS WEBSTER DIAGNOSTIC DEFLECTABLE TIP CATHETER, MODEL D-1078 | DRF | Substantially Equivalent | Cordis Webster, Inc. | accessdata.fda.gov |
| August 28, 1998 | K982740 | CORDIS WEBSTER PREFACE BRAIDED GUIDING SHEATH & PERRY EXCHANGE DILATOR, MODEL #'S 301-803A, 301-803P, 301-803M, 301-813S | DYB | Substantially Equivalent | Cordis Webster, Inc. | accessdata.fda.gov |
| August 10, 1998 | K982415 | CORDIS WEBSTER REF-STAR EXTERNAL REFERENCE PATCH, MODEL # D-1210 | DRF | Substantially Equivalent | Cordis Webster, Inc. | accessdata.fda.gov |
| May 28, 1998 | K980961 | CORDIS WEBSTER REF-STAR EX SURFACE REFERENCE DEVICE MODEL'S D-1204-01, -02,-03, AND -04. | DRF | Substantially Equivalent | Cordis Webster, Inc. | accessdata.fda.gov |
| October 28, 1997 | K970264 | CORDIS WEBSTER BRAIDED GUIDING SHEATH EXCHANGE SYSTEM | DYB | Substantially Equivalent | Cordis Webster, Inc. | accessdata.fda.gov |
| September 18, 1996 | K953663 | CORDIS WEBSTER T20 DIAGNOSTIC DEFLECTABLE TIP CATHETER | DRF | Substantially Equivalent | Cordis Webster, Inc. | accessdata.fda.gov |
| March 25, 1996 | K955817 | CORIDIS WEBSTER DEFLECTABLE BRAIDED-TIP ELECTRODE CATHETER | DRF | Substantially Equivalent | Cordis Webster, Inc. | accessdata.fda.gov |
| November 22, 1995 | K953768 | CORDIS WEBSTER A20 DIAGNOSTIC DEFLECTABLE TIP CATHETER | DRF | Substantially Equivalent | Cordis Webster, Inc. | accessdata.fda.gov |
| December 3, 1985 | K853383 | CARDIOVASCULAR, THERMODILUTION, FLOW, CORONARY SIN | DYG | Substantially Equivalent | Webster Laboratories, Inc. | accessdata.fda.gov |
| May 9, 1984 | K834602 | SWITCHING UNIT ELECTRODE CATHETER | DRF | Substantially Equivalent | Webster Laboratories, Inc. | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| November 6, 2024 | P240006 | VARIPULSE Platform (VARIPULSE Catheter; TRUPULSE Generator; Sterile Interface Cable; nGEN Pump) | QZI | 16 | September 15, 2026 | accessdata.fda.gov |
| November 23, 2022 | P210027 | QDOT MICRO System | OAE | 18 | September 15, 2026 | accessdata.fda.gov |
| August 11, 2006 | P040036 | NAVISTAR THERMOCOOL DEFLECTABLE DIAGNOSTIC/ABLATION CATHETER | LPB | 92 | September 15, 2026 | accessdata.fda.gov |
| November 5, 2004 | P030031 | BIOSENSE WEBSTER NAVISTAR/CELSIUS THERMO COOL DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETERS | OAD | 135 | September 15, 2026 | accessdata.fda.gov |
| September 27, 2002 | P010068 | NAVISTAR/CELSIUS DS DIAGNOSTIC/ABLATION DEFLECTABLE 8MM TIP CATHETER | OAD | 73 | February 26, 2025 | accessdata.fda.gov |
| June 15, 2000 | P990025 | NAVI-STAR DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETER | DRF | 72 | February 25, 2025 | accessdata.fda.gov |
| May 31, 2000 | P990071 | STOCKERT 70 RADIOFREQUENCY ABLATION GENERATOR | LPB | 65 | December 23, 2025 | accessdata.fda.gov |
| September 30, 1997 | P950005 | WEBSTER DIAG./ABLATION DEFLECTABLE TIP CATHETER | LPB | 86 | February 26, 2025 | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| January 5, 2025 | 96170 | Class I | Terminated | VARIPULSE Bi-Directional Ablation Catheter REF D141201. The Field Catheter is indicated for use in catheter based cardiac electrophysiological mapping (stimulating and recording) and, when used for TRUPULSE Generator, fo | Due to an observed trend of neurovascular events | accessdata.fda.gov |
| February 16, 2024 | 94014 | Class II | Ongoing | CARTO VIZIGO Bi-Directional Guiding Sheath, REF D128502 The CARTO VIZIGOTM Bi-Directional Guiding Sheath is designed to provide accessibility and maneuverability in the cardiac anatomy. The steerable sheath is fitted wit | Due to a manufacturing issue, device under process validation phase were inadvertently mixed into the main manufacturing process. | accessdata.fda.gov |
| February 21, 2023 | 91797 | Class II | Ongoing | Biosense Webster Carto Vizigo Bi-Directional Guiding Sheath, 8.5F(Small), REF D-1385-01-S, RX CE 2797, Sterile | Incorrect labeling; specifically, the product name, lot number and product code on the carton label for Bi-Directional Guiding Sheaths does not match the inner label pouch | accessdata.fda.gov |
| April 22, 2020 | 85559 | Class II | Terminated | PENTARAY NAV HIGH-DENSITY MAPPING CATHETER ELECTRODE EA 22 Rx only STERILE EO - Product Usage: The Biosense Webster PENTARAY NAV High-Density Mapping Catheter is indicated for multiple electrode electrophysiological mapp | Mapping Catheter can become entrapped in the cardiac valvular apparatus while the user is attempting to create an electroanatomic map. | accessdata.fda.gov |
Compare with other makers
- All makers of Catheter, Electrode Recording, Or Probe, Electrode Recording
- All makers of Catheter, Ultrasound, Intravascular
- All makers of Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation
- All makers of Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter
- All makers of Catheter, Intracardiac Mapping, High-Density Array
- All makers of Cardiac Ablation Percutaneous Catheter
Updated September 15, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.