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Biosense Webster, Inc.

73 FDA 510(k) clearances · Manufacturer

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RecordFirmDate
CARTO™ 3 EP Navigation System V8.4 (K252972)Biosense Webster, Inc.2026-02-20
CARTO™ 3 EP Navigation System V9.0 with PIU Plus (K254085)Biosense Webster, Inc.2026-01-18
CARTO™ 3 EP Navigation System V8.1 (K252302)Biosense Webster, Inc.2025-08-22
NUVISION™ Ultrasound Catheter; NUVISION™ NAV Ultrasound Catheter (K241540)Biosense Webster, Inc.2024-06-28
SOUNDSTAR™ CRYSTAL Ultrasound Catheter (K240050)Biosense Webster, Inc.2024-06-12
CARTO™ 3 EP Navigation System Software V8.0 (FG-5400-00, FG-5400-00U) (K231207)Biosense Webster, Inc.2023-09-07
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 (K231312)Biosense Webster, Inc.2023-07-10
CARTO VIZIGO® 8.5F Bi-Directional Guiding Sheath (D-1385-01-S, D-1385-02-S, D-1385-03-S) (K231412)Biosense Webster, Inc.2023-07-10
OPTRELL™ Mapping Catheter with TRUEref™ Technology (K230253)Biosense Webster, Inc.2023-03-02
CARTO® 3 EP Navigation System with CARTOSOUND™ 4D Version 7.4 (K223733)Biosense Webster, Inc.2023-02-16
NUVISION™ NAV Ultrasound Catheter (K223766)Biosense Webster, Inc.2023-02-16
CARTO 3 EP Navigation System with Advanced Focus Mapping (AFM) (K221112)Biosense Webster, Inc.2022-08-17
OPTRELL Mapping Catheter with TRUEref Technology (K211438)Biosense Webster, Inc.2022-03-18
LASSOSTAR NAV Circular Mapping Catheter (K211219)Biosense Webster, Inc.2022-01-26
CARTO 3 EP Navigation System Version 7.2 (K213264)Biosense Webster, Inc.2021-10-29
CARTO® 3 EP Navigation System with Signal Processing Unit (K200484)Biosense Webster, Inc.2020-11-25
Pentaray Nav eco High-Density Mapping Catheter (K201750)Biosense Webster, Inc.2020-08-06
Carto Octaray Mapping Catheter with Trueref Technology (K193237)Biosense Webster, Inc.2020-07-31
LassoStar Circular Mapping Catheter (K193632)Biosense Webster, Inc.2020-06-30
CARTO 3 EP Navigation System, Version 7.1 and Accessories (K191660)Biosense Webster, Inc.2019-07-20
CARTO 3 EP Navigation System, Version 5.2 and Accessories with CARTOFINDER Module (K173978)Biosense Webster, Inc.2018-08-24
CARTO 3 EP Navigation System, Version 4.35 and Accessories with COHERENT MAP Module (K173977)Biosense Webster, Inc.2018-06-14
CARTO 3 EP Navigation System, Version 6.0 and Accessories with VISITAG SURPOINT (K180238)Biosense Webster, Inc.2018-06-01
CARTO 3 EP Navigation System, Version 6.0 and Accessories (K170600)Biosense Webster, Inc.2017-07-25
CARTO VIZIGO 8.5F Bi-Directional Guiding Sheath (K170997)Biosense Webster, Inc.2017-07-25
CARTO 3 EP NAVIGATION SYSTEM, VERSION 4.2 (K133916)Biosense Webster, Inc.2014-07-01
CARTO3 EP NAVIGATION SYSTEM, VERSION 3.2 (K132782)Biosense Webster, Inc.2014-01-24
LASSO NAV DUO LOOP CATHETER (K130602)Biosense Webster, Inc.2013-08-14
PENTARAY NAV ECO HIGH-DENSITY MAPPING CATHETER (K123837)Biosense Webster, Inc.2013-03-05
PENTARAY NAV HIGH-DENSITY MAPPING CATHETER (K120425)Biosense Webster, Inc.2012-05-24
CARTO(R) EP NAVIGATION SYSTEM, VERSION 3.0 (WITH STANDARD LOCATION PAD) (K120550)Biosense Webster, Inc.2012-05-07
LASSO 2515 NAV ECO VARIABLE CATHETER LASSO NAV ECO CATHETER CONTINUED FROM LINE 2 (K113213)Biosense Webster, Inc.2011-12-05
SOUNDSTAR ECO DIAGNOSTIC ULTRASOUND CATHETER (K112050)Biosense Webster, Inc.2011-11-18
CARTO 3 EP NAVIGATION SYSTEM, VERSION 2.2 (K112007)Biosense Webster, Inc.2011-10-05
WEBSTER DUO-DECAPOLAR CATHETER (K101991)Biosense Webster, Inc.2011-05-02
CARTO 3 EP NAVIGATION SYSTEM, VERSION 2.0 (W/STANDARD LOCATION PAD),CARTO3 EPNAVIGATION SYSTEM,VERSION 2.0 W/RMT PAD) (K103746)Biosense Webster, Inc.2011-01-21
WEBSTER CS CATHETER WITH EZ STEER TECHNOLOGY, WEBSTER CS CATHETER WITH EZ STEER TECHNOLOGY AND AUTO ID MODEL: D-1263-04, (K101345)Biosense Webster, Inc.2010-06-22
SOUNDSTAR 3D ULTRASOUND CATHETER MODEL M-5723-12 (K101138)Biosense Webster, Inc.2010-06-22
CARTO XP EP NAVIGATION SYSTEM, VERSION 10 (K093566)Biosense Webster, Inc.2010-06-18
LASSO NAV CATHETER (K093376)Biosense Webster, Inc.2010-06-18
SOUNDSTAR 3D DIAGNOSTIC CATHETER, MODEL M-5723-05 (K091352)Biosense Webster, Inc.2009-12-04
CARTO 3 VERSION 1.05 EP NAVIGATION SYSTEM AND ACCESSORIES (K093455)Biosense Webster, Inc.2009-12-04
CARTO 3 EP NAVIGATION SYSTEM, V1.0 AND ACCESSORIES (K090017)Biosense Webster, Inc.2009-10-13
CARTO RMT EP NAVIGATION SYSTEM V8 (K091789)Biosense Webster, Inc.2009-10-01
CORONARY SINUS DEFLECTABLE MAPPING CATHETER, MODEL D-1263-01, WEBSTER CS CATHETER WITH EZ STEER (K090898)Biosense Webster, Inc.2009-09-04
SOUNDSTAR 3D ULTRASOUND CATHETER, MODEL M-5723-12 (K092064)Biosense Webster, Inc.2009-08-07
REFSTAR PLUS WITH QWIKPATCH EXTERNAL REFERENCE PATCH, MODEL D-1210-03, REFSTAR PLUS CABLE, MODEL M-4700-106 (K090120)Biosense Webster, Inc.2009-03-24
VARIABLE LASSO NAV CATHETER, MODELS: D-1290-01, D-1290-02 (K081258)Biosense Webster, Inc.2009-01-06
CS REFSTAR CATHETER (D- AND F-CURVES), MODELS D-1285-01 AND D-1285-02 (K080425)Biosense Webster, Inc.2008-04-23
CARTO 3 NAVIGATION SYSTEM (MODEL:FG-5400-00), CARTO 3 EXTERNAL REFERENCE PATCHES (MODEL:D-1283-01) (K072202)Biosense Webster, Inc.2007-11-19
SOUNDSTAR 3D ULTRASOUND CATHETER, MODEL M-5723-05 (K070242)Biosense Webster, Inc.2007-05-15
CARTO XP EP NAVIGATION SYSTEM, VERSION 9 (K070240)Biosense Webster, Inc.2007-05-04
REFSTAR EXTERNAL REFERENCE PATCH (K061468)Biosense Webster, Inc.2006-08-14
ESOPHAGEAL MAPPING CATHETER, MODEL D-1272-01-S (K061463)Biosense Webster, Inc.2006-08-14
CARTO RMT EP NAVIGATION SYSTEM V8 (K060047)Biosense Webster, Inc.2006-06-19
NOGA XP CARDIAC NAVIGATION SYSTEM WITH QWIKMAP SOFTWARE (K053194)Biosense Webster, Inc.2006-03-09
CARTO RMT EP NAVIGATION SYSTEM (K042681)Biosense Webster, Inc.2005-09-29
NAVISTAR RMT STEERABLE TIP DIAGNOSTIC CATHETER (K052083)Biosense Webster, Inc.2005-09-29
REFSTAR RMT EXTERNAL REFERENCE PATCH (K042998)Biosense Webster, Inc.2005-09-29
CORONARY SINUS DEFLECTABLE MAPPING CATHETER, 4 FR, 5 FR, 6 FR & 7 FR (K050877)Biosense Webster, Inc.2005-06-24
FLOWER HIGH-DENSITY MAPPING CATHETER, 4-4-4 MM ELECTRODE SPACING), (2-6-2 MM ELECTRODE SPACING) (K050217)Biosense Webster, Inc.2005-03-30
CARTO XP EP NAVIGATION SYSTEM, SOFTWARE VERISON 8 (K042999)Biosense Webster, Inc.2005-03-21
VARIABLE LASSO 2515 CIRCULAR MAPPING CATHETER (K031161)Biosense Webster, Inc.2003-07-22
CARTO XP AND QWIKMAP EP NAVIGATION SYSTEM (K020863)Biosense Webster, Inc.2003-01-09
CARTO XP EP NAVIGATION SYSTEM (K013083)Biosense Webster, Inc.2001-11-21
BIOSENSE WEBSTER LASSO DEFLECTABLE CIRCULAR MAPPING CATHETER, MODEL D-1220 (K002333)Biosense Webster, Inc.2000-08-31
BIOSENSE WEBSTER PATIENT CABLE AND LEADWIRES (K001390)Biosense Webster, Inc.2000-07-21
PREFACE GUIDING SHEATH, MODELS 2-603M, 2-703M, 2-803M, 2-903M, 2-1003M, 2-1103M (K001139)Biosense Webster, Inc.2000-05-10
CARTO EP NAVIGATION SYSTEM (K000248)Biosense Webster, Inc.2000-05-05
MODIFICATION TO CARTO EP NAVIGATION SYSTEM (K000190)Biosense Webster, Inc.2000-05-05
NOGA CARDIAC NAVIGATION SYSTEM (K000332)Biosense Webster, Inc.2000-05-04
MODIFICATION TO CARTO EP NAVIGATION SYSTEM (K993729)Biosense Webster, Inc.1999-12-03
CARTO EP NAVIGATION SYSTEM (K992968)Biosense Webster, Inc.1999-09-29

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