FDA 510(k) Applications Submitted by Biosense Webster, Inc.
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K000248 |
01/27/2000 |
CARTO EP NAVIGATION SYSTEM |
BIOSENSE WEBSTER, INC. |
| K000332 |
02/03/2000 |
NOGA CARDIAC NAVIGATION SYSTEM |
BIOSENSE WEBSTER, INC. |
| K013083 |
09/14/2001 |
CARTO XP EP NAVIGATION SYSTEM |
BIOSENSE WEBSTER, INC. |
| K090017 |
01/02/2009 |
CARTO 3 EP NAVIGATION SYSTEM, V1.0 AND ACCESSORIES |
BIOSENSE WEBSTER, INC. |
| K090120 |
01/21/2009 |
REFSTAR PLUS WITH QWIKPATCH EXTERNAL REFERENCE PATCH, MODEL D-1210-03, REFSTAR PLUS CABLE, MODEL M-4700-106 |
BIOSENSE WEBSTER, INC. |
| K080425 |
02/15/2008 |
CS REFSTAR CATHETER (D- AND F-CURVES), MODELS D-1285-01 AND D-1285-02 |
BIOSENSE WEBSTER, INC. |
| K091352 |
05/07/2009 |
SOUNDSTAR 3D DIAGNOSTIC CATHETER, MODEL M-5723-05 |
BIOSENSE WEBSTER, INC. |
| K101345 |
05/13/2010 |
WEBSTER CS CATHETER WITH EZ STEER TECHNOLOGY, WEBSTER CS CATHETER WITH EZ STEER TECHNOLOGY AND AUTO ID MODEL: D-1263-04, |
BIOSENSE WEBSTER, INC. |
| K101991 |
07/14/2010 |
WEBSTER DUO-DECAPOLAR CATHETER |
BIOSENSE WEBSTER, INC. |
| K093455 |
11/05/2009 |
CARTO 3 VERSION 1.05 EP NAVIGATION SYSTEM AND ACCESSORIES |
BIOSENSE WEBSTER, INC. |
| K231207 |
04/27/2023 |
CARTOÖ 3 EP Navigation System Software V8.0 (FG-5400-00, FG-5400-00U) |
Biosense Webster, Inc. |
| K231412 |
05/16/2023 |
CARTO VIZIGO« 8.5F Bi-Directional Guiding Sheath (D-1385-01-S, D-1385-02-S, D-1385-03-S) |
Biosense Webster, Inc. |
| K060047 |
01/06/2006 |
CARTO RMT EP NAVIGATION SYSTEM V8 |
BIOSENSE WEBSTER, INC. |
| K091789 |
06/17/2009 |
CARTO RMT EP NAVIGATION SYSTEM V8 |
BIOSENSE WEBSTER, INC. |
| K042681 |
09/29/2004 |
CARTO RMT EP NAVIGATION SYSTEM |
BIOSENSE WEBSTER, INC. |
| K052083 |
08/02/2005 |
NAVISTAR RMT STEERABLE TIP DIAGNOSTIC CATHETER |
BIOSENSE WEBSTER, INC. |
| K230253 |
01/31/2023 |
OPTRELLÖ Mapping Catheter with TRUErefÖ Technology |
Biosense Webster, Inc. |
| K130602 |
03/07/2013 |
LASSO NAV DUO LOOP CATHETER |
BIOSENSE WEBSTER, INC. |
| K170997 |
04/03/2017 |
CARTO VIZIGO 8.5F Bi-Directional Guiding Sheath |
Biosense Webster, Inc. |
| K211438 |
05/10/2021 |
OPTRELL Mapping Catheter with TRUEref Technology |
Biosense Webster, Inc. |
| K113213 |
11/01/2011 |
LASSO 2515 NAV ECO VARIABLE CATHETER LASSO NAV ECO CATHETER CONTINUED FROM LINE 2 |
BIOSENSE WEBSTER, INC. |
| K200484 |
02/27/2020 |
CARTO« 3 EP Navigation System with Signal Processing Unit |
Biosense Webster, Inc. |
| K213264 |
09/30/2021 |
CARTO 3 EP Navigation System Version 7.2 |
Biosense Webster, Inc. |
| K001390 |
05/02/2000 |
BIOSENSE WEBSTER PATIENT CABLE AND LEADWIRES |
BIOSENSE WEBSTER, INC. |
| K002333 |
08/01/2000 |
BIOSENSE WEBSTER LASSO DEFLECTABLE CIRCULAR MAPPING CATHETER, MODEL D-1220 |
BIOSENSE WEBSTER, INC. |
| K112050 |
07/18/2011 |
SOUNDSTAR ECO DIAGNOSTIC ULTRASOUND CATHETER |
BIOSENSE WEBSTER, INC. |
| K042999 |
11/01/2004 |
CARTO XP EP NAVIGATION SYSTEM, SOFTWARE VERISON 8 |
BIOSENSE WEBSTER, INC. |
| K042998 |
11/01/2004 |
REFSTAR RMT EXTERNAL REFERENCE PATCH |
BIOSENSE WEBSTER, INC. |
| K001139 |
04/10/2000 |
PREFACE GUIDING SHEATH, MODELS 2-603M, 2-703M, 2-803M, 2-903M, 2-1003M, 2-1103M |
BIOSENSE WEBSTER, INC. |
| K092064 |
07/08/2009 |
SOUNDSTAR 3D ULTRASOUND CATHETER, MODEL M-5723-12 |
BIOSENSE WEBSTER, INC. |
| K101138 |
04/22/2010 |
SOUNDSTAR 3D ULTRASOUND CATHETER MODEL M-5723-12 |
BIOSENSE WEBSTER, INC. |
| K050877 |
04/06/2005 |
CORONARY SINUS DEFLECTABLE MAPPING CATHETER, 4 FR, 5 FR, 6 FR & 7 FR |
BIOSENSE WEBSTER, INC. |
| K211219 |
04/23/2021 |
LASSOSTAR NAV Circular Mapping Catheter |
Biosense Webster, Inc. |
| K193632 |
12/27/2019 |
LassoStar Circular Mapping Catheter |
Biosense Webster, Inc. |
| K090898 |
04/01/2009 |
CORONARY SINUS DEFLECTABLE MAPPING CATHETER, MODEL D-1263-01, WEBSTER CS CATHETER WITH EZ STEER |
BIOSENSE WEBSTER, INC. |
| K081258 |
05/02/2008 |
VARIABLE LASSO NAV CATHETER, MODELS: D-1290-01, D-1290-02 |
BIOSENSE WEBSTER, INC. |
| K061463 |
05/26/2006 |
ESOPHAGEAL MAPPING CATHETER, MODEL D-1272-01-S |
BIOSENSE WEBSTER, INC. |
| K061468 |
05/26/2006 |
REFSTAR EXTERNAL REFERENCE PATCH |
BIOSENSE WEBSTER, INC. |
| K072202 |
08/08/2007 |
CARTO 3 NAVIGATION SYSTEM (MODEL:FG-5400-00), CARTO 3 EXTERNAL REFERENCE PATCHES (MODEL:D-1283-01) |
BIOSENSE WEBSTER, INC. |
| K070240 |
01/25/2007 |
CARTO XP EP NAVIGATION SYSTEM, VERSION 9 |
BIOSENSE WEBSTER, INC. |
| K070242 |
02/09/2007 |
SOUNDSTAR 3D ULTRASOUND CATHETER, MODEL M-5723-05 |
BIOSENSE WEBSTER, INC. |
| K170600 |
03/01/2017 |
CARTO 3 EP Navigation System, Version 6.0 and Accessories |
Biosense Webster, Inc. |
| K180238 |
01/29/2018 |
CARTO 3 EP Navigation System, Version 6.0 and Accessories with VISITAG SURPOINT |
Biosense Webster, Inc. |
| K191660 |
06/21/2019 |
CARTO 3 EP Navigation System, Version 7.1 and Accessories |
Biosense Webster, Inc. |
| K173978 |
12/29/2017 |
CARTO 3 EP Navigation System, Version 5.2 and Accessories with CARTOFINDER Module |
Biosense Webster, Inc. |
| K173977 |
12/29/2017 |
CARTO 3 EP Navigation System, Version 4.35 and Accessories with COHERENT MAP Module |
Biosense Webster, Inc. |
| K221112 |
04/15/2022 |
CARTO 3 EP Navigation System with Advanced Focus Mapping (AFM) |
Biosense Webster, Inc. |
| K223733 |
12/13/2022 |
CARTO« 3 EP Navigation System with CARTOSOUNDÖ 4D Version 7.4 |
Biosense Webster, Inc. |
| K193237 |
11/25/2019 |
Carto Octaray Mapping Catheter with Trueref Technology |
Biosense Webster, Inc. |
| K992968 |
09/03/1999 |
CARTO EP NAVIGATION SYSTEM |
BIOSENSE WEBSTER, INC. |
| K993729 |
11/04/1999 |
MODIFICATION TO CARTO EP NAVIGATION SYSTEM |
BIOSENSE WEBSTER, INC. |
| K223766 |
12/15/2022 |
NUVISIONÖ NAV Ultrasound Catheter |
Biosense Webster, Inc. |
| K000190 |
01/13/2000 |
MODIFICATION TO CARTO EP NAVIGATION SYSTEM |
BIOSENSE WEBSTER, INC. |
| K053194 |
11/15/2005 |
NOGA XP CARDIAC NAVIGATION SYSTEM WITH QWIKMAP SOFTWARE |
BIOSENSE WEBSTER, INC. |
| K093376 |
10/29/2009 |
LASSO NAV CATHETER |
BIOSENSE WEBSTER, INC. |
| K050217 |
01/31/2005 |
FLOWER HIGH-DENSITY MAPPING CATHETER, 4-4-4 MM ELECTRODE SPACING), (2-6-2 MM ELECTRODE SPACING) |
BIOSENSE WEBSTER, INC. |
| K120425 |
02/13/2012 |
PENTARAY NAV HIGH-DENSITY MAPPING CATHETER |
BIOSENSE WEBSTER, INC. |
| K120550 |
02/23/2012 |
CARTO(R) EP NAVIGATION SYSTEM, VERSION 3.0 (WITH STANDARD LOCATION PAD) |
BIOSENSE WEBSTER, INC. |
| K112007 |
07/14/2011 |
CARTO 3 EP NAVIGATION SYSTEM, VERSION 2.2 |
BIOSENSE WEBSTER, INC. |
| K132782 |
09/06/2013 |
CARTO3 EP NAVIGATION SYSTEM, VERSION 3.2 |
BIOSENSE WEBSTER, INC. |
| K093566 |
11/18/2009 |
CARTO XP EP NAVIGATION SYSTEM, VERSION 10 |
BIOSENSE WEBSTER, INC. |
| K123837 |
12/13/2012 |
PENTARAY NAV ECO HIGH-DENSITY MAPPING CATHETER |
BIOSENSE WEBSTER, INC. |
| K103746 |
12/23/2010 |
CARTO 3 EP NAVIGATION SYSTEM, VERSION 2.0 (W/STANDARD LOCATION PAD),CARTO3 EPNAVIGATION SYSTEM,VERSION 2.0 W/RMT PAD) |
BIOSENSE WEBSTER, INC. |
| K133916 |
12/23/2013 |
CARTO 3 EP NAVIGATION SYSTEM, VERSION 4.2 |
BIOSENSE WEBSTER, INC. |
| K020863 |
03/18/2002 |
CARTO XP AND QWIKMAP EP NAVIGATION SYSTEM |
BIOSENSE WEBSTER, INC. |
| K031161 |
04/14/2003 |
VARIABLE LASSO 2515 CIRCULAR MAPPING CATHETER |
BIOSENSE WEBSTER, INC. |
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