# Biosense Webster, Inc.

- Location (FDA's records): Diamond Bar, CA
- FDA decisions: 84 (1997–2026): 76 510(k) clearances and 8 original PMA approvals
- Names in FDA's records: Biosense Webster, Inc. (81); Biosense Webster (3)
- Product codes: DQK (34), DRF (20), OBJ (9), MTD (8), LPB (3), DYB (3), PGW (2), OAD (2), QZI (1), OAE (1), DSA (1)
- 510(k) review time since 2016: median 123 days, against 132 for FDA's reviews in the same codes and years (11 of 25 faster)
- Predicates its devices cite: 99 (72 its own); citations of its devices by later devices: 142 (72 its own)
- Recalls linked to its devices: 50 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Cordis Webster, Inc.: 11 (https://510kreport.com/company/cordis-webster)
- Fiagon GmbH: 2 (https://510kreport.com/company/fiagon)
- Nuvera Medical, Inc.: 2 (https://510kreport.com/company/nuvera-medical)
- Siemens Medical Solutions USA, Inc.: 2 (https://510kreport.com/company/siemens-medical-solutions-usa)
- St Jude Medical: 2 (https://510kreport.com/company/st-jude-medical)
- Acclarent, Inc.: 1 (https://510kreport.com/company/acclarent)
- St. Jude Medical, Inc.-Endocardial Solutions: 1 (https://510kreport.com/company/st-jude-medical-endocardial-solutions)
- Boston Scientific Corp: 1 (https://510kreport.com/company/boston-scientific)

## Firms that cite its devices most
- Innovative Health, LLC: 12 (https://510kreport.com/company/innovative-health)
- Sterilmed, Inc.: 10 (https://510kreport.com/company/sterilmed)
- Ep Medsystems: 8 (https://510kreport.com/company/ep-medsystems)
- Ascent Healthcare Solutions: 4 (https://510kreport.com/company/ascent-healthcare-solutions)
- Boston Scientific Corp: 4 (https://510kreport.com/company/boston-scientific)
- Stryker Sustainability Solutions: 4 (https://510kreport.com/company/stryker-sustainability-solutions)
- Medtronic, Inc.: 3 (https://510kreport.com/company/medtronic)
- Surgical Instrument Service and Savings, Inc.: 2 (https://510kreport.com/company/surgical-instrument-service-and-savings)

## Its most-cited devices
- K101345: Webster CS Catheter with EZ Steer Technology, Webster CS Catheter with EZ Steer Technology and Auto ID Model: D-1263-04, (2010), cited by 9
- K002333: Biosense Webster Lasso Deflectable Circular Mapping Catheter, Model D-1220 (2000), cited by 6
- K133916: Carto 3 EP Navigation System, Version 4.2 (2014), cited by 6
- K070242: Soundstar 3D Ultrasound Catheter, Model M-5723-05 (2007), cited by 5
- K113213: Lasso 2515 Nav Eco Variable Catheter Lasso Nav Eco Catheter Continued From Line 2 (2011), cited by 4
- K123837: Pentaray Nav Eco High-Density Mapping Catheter (2013), cited by 4

## Recent decisions
- K252972: CARTO™ 3 EP Navigation System V8.4 (Feb 20, 2026)
- K254085: CARTO™ 3 EP Navigation System V9.0 with PIU Plus (Jan 18, 2026)
- K252302: CARTO™ 3 EP Navigation System V8.1 (Aug 22, 2025)
- P240006: VARIPULSE™ Platform (VARIPULSE™ Catheter; TRUPULSE™ Generator; Sterile Interface Cable; nGEN™ Pump) (Nov 6, 2024)
- K241540: NUVISION™ Ultrasound Catheter; NUVISION™ NAV Ultrasound Catheter (Jun 28, 2024)
- K240050: SOUNDSTAR™ CRYSTAL Ultrasound Catheter (Jun 12, 2024)
- K231207: CARTO™ 3 EP Navigation System Software V8.0 (FG-5400-00, FG-5400-00U) (Sep 7, 2023)
- K231412: CARTO VIZIGO® 8.5F Bi-Directional Guiding Sheath (D-1385-01-S, D-1385-02-S, D-1385-03-S) (Jul 10, 2023)

Source page: https://510kreport.com/company/biosense-webster