ThermoCool SmartTouch
BIOSENSE WEBSTER, INC.
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3013300026 | 3013300026 | BIOSENSE WEBSTER, INC. | 1 | Y | 2026-01-01 | 31 Technology Drive, Suite 200 -- Irvine CA US 92618 |
| 3022451073 | 3022451073 | BIOSENSE WEBSTER, INC. | 1 | N | 2026-01-01 | 23 Hubble Drive Irvine CA US 92618 |
| 2020638 | 2020638 | BIOSENSE WEBSTER, INC. | 1 | Y | 2020-04-25 | 5110 COMMERCE RD. BALDWIN PARK CA US 91706 |
| 2029046 | 3003113629 | BIOSENSE WEBSTER, INC. | 1 | Y | 2020-04-25 | 15715 ARROW HWY. IRWINDALE CA US 91706 |
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 58743 | 1452071458 | P990071 | STOCKERT 70 RADIOFREQUENCY ABLATION GENERATOR | LPB | 2000-05-31 |
| 58742 | 1452071458 | P990071 | STOCKERT 70 RADIOFREQUENCY ABLATION GENERATOR | LPB | 2000-05-31 |
| 308348 | 1452071458 | P990071 | STOCKERT 70 RADIOFREQUENCY ABLATION GENERATOR | LPB | 2000-05-31 |
| 58742 | 1419020728 | P990025 | NAVI-STAR DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETER | DRF | 2000-06-15 |
| 58743 | 1419020728 | P990025 | NAVI-STAR DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETER | DRF | 2000-06-15 |
| 308348 | 1419020728 | P990025 | NAVI-STAR DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETER | DRF | 2000-06-15 |
| 58742 | 1559194504 | P950005 | WEBSTER DIAG./ABLATION DEFLECTABLE TIP CATHETER | LPB | 1997-09-30 |
| 58743 | 1559194504 | P950005 | WEBSTER DIAG./ABLATION DEFLECTABLE TIP CATHETER | LPB | 1997-09-30 |
| 308348 | 1559194504 | P950005 | WEBSTER DIAG./ABLATION DEFLECTABLE TIP CATHETER | LPB | 1997-09-30 |
| 308348 | 1163060217 | P240006 | VARIPULSE™ Platform (VARIPULSE™ Catheter; TRUPULSE™ Generator; Sterile Interface Cable; nGEN™ Pump) | QZI | 2024-11-06 |
| 308348 | 1316897506 | P210027 | QDOT MICRO™ System | OAE | 2022-11-23 |
| 58742 | 1165329946 | P040036 | NAVISTAR THERMOCOOL DEFLECTABLE DIAGNOSTIC/ABLATION CATHETER | LPB | 2006-08-11 |
| 58743 | 1165329946 | P040036 | NAVISTAR THERMOCOOL DEFLECTABLE DIAGNOSTIC/ABLATION CATHETER | LPB | 2006-08-11 |
| 308348 | 1165329946 | P040036 | NAVISTAR THERMOCOOL DEFLECTABLE DIAGNOSTIC/ABLATION CATHETER | LPB | 2006-08-11 |
| 58743 | 1612366345 | P030031 | BIOSENSE WEBSTER NAVISTAR/CELSIUS THERMO COOL DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETERS | OAD | 2004-11-05 |
| 58742 | 1612366345 | P030031 | BIOSENSE WEBSTER NAVISTAR/CELSIUS THERMO COOL DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETERS | OAD | 2004-11-05 |
| 308348 | 1612366345 | P030031 | BIOSENSE WEBSTER NAVISTAR/CELSIUS THERMO COOL DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETERS | OAD | 2004-11-05 |
| 58743 | 1366746373 | P010068 | NAVISTAR/CELSIUS DS DIAGNOSTIC/ABLATION DEFLECTABLE 8MM TIP CATHETER | OAD | 2002-09-27 |
| 58742 | 1366746373 | P010068 | NAVISTAR/CELSIUS DS DIAGNOSTIC/ABLATION DEFLECTABLE 8MM TIP CATHETER | OAD | 2002-09-27 |
| 308348 | 1366746373 | P010068 | NAVISTAR/CELSIUS DS DIAGNOSTIC/ABLATION DEFLECTABLE 8MM TIP CATHETER | OAD | 2002-09-27 |
| 58743 | 1148648591 | K992965 | CORDIS WEBSTER FIXED CURVE CATHETERS, MODELS D-1124, D-1085 | DRF | 1999-11-26 |
| 58742 | 1148648591 | K992965 | CORDIS WEBSTER FIXED CURVE CATHETERS, MODELS D-1124, D-1085 | DRF | 1999-11-26 |
| 308348 | 1148648591 | K992965 | CORDIS WEBSTER FIXED CURVE CATHETERS, MODELS D-1124, D-1085 | DRF | 1999-11-26 |
| 58743 | 1367532919 | K991531 | CORDIS WEBSTER DIAGNOSTIC DEFLECTABLE TIP CATHETER, MODEL D-1078 | DRF | 1999-10-04 |
| 58742 | 1367532919 | K991531 | CORDIS WEBSTER DIAGNOSTIC DEFLECTABLE TIP CATHETER, MODEL D-1078 | DRF | 1999-10-04 |
| 308348 | 1367532919 | K991531 | CORDIS WEBSTER DIAGNOSTIC DEFLECTABLE TIP CATHETER, MODEL D-1078 | DRF | 1999-10-04 |
| 58743 | 1780546532 | K982740 | CORDIS WEBSTER PREFACE BRAIDED GUIDING SHEATH & PERRY EXCHANGE DILATOR, MODEL #'S 301-803A, 301-803P, 301-803M, 301-813S | DYB | 1998-08-28 |
| 308348 | 1780546532 | K982740 | CORDIS WEBSTER PREFACE BRAIDED GUIDING SHEATH & PERRY EXCHANGE DILATOR, MODEL #'S 301-803A, 301-803P, 301-803M, 301-813S | DYB | 1998-08-28 |
| 58742 | 1063935976 | K982415 | CORDIS WEBSTER REF-STAR EXTERNAL REFERENCE PATCH, MODEL # D-1210 | DRF | 1998-08-10 |
| 58743 | 1063935976 | K982415 | CORDIS WEBSTER REF-STAR EXTERNAL REFERENCE PATCH, MODEL # D-1210 | DRF | 1998-08-10 |
| 308348 | 1063935976 | K982415 | CORDIS WEBSTER REF-STAR EXTERNAL REFERENCE PATCH, MODEL # D-1210 | DRF | 1998-08-10 |
| 58742 | 1078027235 | K980961 | CORDIS WEBSTER REF-STAR EX SURFACE REFERENCE DEVICE MODEL'S D-1204-01, -02,-03, AND -04. | DRF | 1998-05-28 |
| 58743 | 1078027235 | K980961 | CORDIS WEBSTER REF-STAR EX SURFACE REFERENCE DEVICE MODEL'S D-1204-01, -02,-03, AND -04. | DRF | 1998-05-28 |
| 308348 | 1078027235 | K980961 | CORDIS WEBSTER REF-STAR EX SURFACE REFERENCE DEVICE MODEL'S D-1204-01, -02,-03, AND -04. | DRF | 1998-05-28 |
| 58743 | 1942304381 | K970264 | CORDIS WEBSTER BRAIDED GUIDING SHEATH EXCHANGE SYSTEM | DYB | 1997-10-28 |
| 58742 | 1942304381 | K970264 | CORDIS WEBSTER BRAIDED GUIDING SHEATH EXCHANGE SYSTEM | DYB | 1997-10-28 |
| 308348 | 1942304381 | K970264 | CORDIS WEBSTER BRAIDED GUIDING SHEATH EXCHANGE SYSTEM | DYB | 1997-10-28 |
| 58742 | 1425029505 | K955817 | CORIDIS WEBSTER DEFLECTABLE BRAIDED-TIP ELECTRODE CATHETER | DRF | 1996-03-25 |
| 58743 | 1425029505 | K955817 | CORIDIS WEBSTER DEFLECTABLE BRAIDED-TIP ELECTRODE CATHETER | DRF | 1996-03-25 |
| 308348 | 1425029505 | K955817 | CORIDIS WEBSTER DEFLECTABLE BRAIDED-TIP ELECTRODE CATHETER | DRF | 1996-03-25 |
| 58743 | 1816500739 | K954390 | CORDIS WESTER STAR CATHETER | DRF | 1995-12-21 |
| 58742 | 1816500739 | K954390 | CORDIS WESTER STAR CATHETER | DRF | 1995-12-21 |
| 308348 | 1816500739 | K954390 | CORDIS WESTER STAR CATHETER | DRF | 1995-12-21 |
| 58743 | 1079815869 | K953768 | CORDIS WEBSTER A20 DIAGNOSTIC DEFLECTABLE TIP CATHETER | DRF | 1995-11-22 |
| 58742 | 1079815869 | K953768 | CORDIS WEBSTER A20 DIAGNOSTIC DEFLECTABLE TIP CATHETER | DRF | 1995-11-22 |
| 308348 | 1079815869 | K953768 | CORDIS WEBSTER A20 DIAGNOSTIC DEFLECTABLE TIP CATHETER | DRF | 1995-11-22 |
| 58743 | 1700098476 | K953663 | CORDIS WEBSTER T20 DIAGNOSTIC DEFLECTABLE TIP CATHETER | DRF | 1996-09-18 |
| 58742 | 1700098476 | K953663 | CORDIS WEBSTER T20 DIAGNOSTIC DEFLECTABLE TIP CATHETER | DRF | 1996-09-18 |
| 308348 | 1700098476 | K953663 | CORDIS WEBSTER T20 DIAGNOSTIC DEFLECTABLE TIP CATHETER | DRF | 1996-09-18 |
| 58742 | 1306939737 | K892265 | |||
| 58743 | 1306939737 | K892265 | |||
| 308348 | 1306939737 | K892265 | |||
| 58742 | 1718281991 | K853383 | CARDIOVASCULAR, THERMODILUTION, FLOW, CORONARY SIN | DYG | 1985-12-03 |
| 58743 | 1718281991 | K853383 | CARDIOVASCULAR, THERMODILUTION, FLOW, CORONARY SIN | DYG | 1985-12-03 |
| 308348 | 1718281991 | K853383 | CARDIOVASCULAR, THERMODILUTION, FLOW, CORONARY SIN | DYG | 1985-12-03 |
| 58742 | 1373562806 | K841802 | ELECTRODE CATHETER, ORTHOGONAL TYPE | LDF | 1984-10-18 |
| 58743 | 1373562806 | K841802 | ELECTRODE CATHETER, ORTHOGONAL TYPE | LDF | 1984-10-18 |
| 58743 | 1836872792 | K834602 | SWITCHING UNIT ELECTRODE CATHETER | DRF | 1984-05-09 |
| 58742 | 1836872792 | K834602 | SWITCHING UNIT ELECTRODE CATHETER | DRF | 1984-05-09 |
| 308348 | 1836872792 | K834602 | SWITCHING UNIT ELECTRODE CATHETER | DRF | 1984-05-09 |
| 308348 | 1526307804 | K254085 | CARTO™ 3 EP Navigation System V9.0 with PIU Plus | DQK | 2026-01-18 |
| 308348 | 1196703283 | K252972 | CARTO™ 3 EP Navigation System V8.4 | DQK | 2026-02-20 |
| 314019 | 1196703283 | K252972 | CARTO™ 3 EP Navigation System V8.4 | DQK | 2026-02-20 |
| 314019 | 1889108606 | K252302 | CARTO™ 3 EP Navigation System V8.1 | DQK | 2025-08-22 |
| 308348 | 1889108606 | K252302 | CARTO™ 3 EP Navigation System V8.1 | DQK | 2025-08-22 |
| 308348 | 1999568673 | K241540 | NUVISION™ Ultrasound Catheter; NUVISION™ NAV Ultrasound Catheter | OBJ | 2024-06-28 |
| 308348 | 2045780395 | K240050 | SOUNDSTAR™ CRYSTAL Ultrasound Catheter | OBJ | 2024-06-12 |
| 308348 | 1570366164 | 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 | 2023-07-10 |
| 308348 | 1259048607 | K231207 | CARTO™ 3 EP Navigation System Software V8.0 (FG-5400-00, FG-5400-00U) | DQK | 2023-09-07 |
| 314019 | 1259048607 | K231207 | CARTO™ 3 EP Navigation System Software V8.0 (FG-5400-00, FG-5400-00U) | DQK | 2023-09-07 |
| 308348 | 1838273211 | K230253 | OPTRELL™ Mapping Catheter with TRUEref™ Technology | MTD | 2023-03-02 |
| 308348 | 2007244677 | K223766 | NUVISION™ NAV Ultrasound Catheter | OBJ | 2023-02-16 |
| 308348 | 1886013154 | K223733 | CARTO® 3 EP Navigation System with CARTOSOUND™ 4D Version 7.4 | DQK | 2023-02-16 |
| 308348 | 1298566348 | K221112 | CARTO 3 EP Navigation System with Advanced Focus Mapping (AFM) | DQK | 2022-08-17 |
| 314019 | 1298566348 | K221112 | CARTO 3 EP Navigation System with Advanced Focus Mapping (AFM) | DQK | 2022-08-17 |
| 308348 | 1446518845 | K213264 | CARTO 3 EP Navigation System Version 7.2 | DQK | 2021-10-29 |
| 314019 | 1446518845 | K213264 | CARTO 3 EP Navigation System Version 7.2 | DQK | 2021-10-29 |
| 308348 | 1626964321 | K211438 | OPTRELL Mapping Catheter with TRUEref Technology | MTD | 2022-03-18 |
| 308348 | 1795239315 | K211219 | LASSOSTAR NAV Circular Mapping Catheter | DRF | 2022-01-26 |
| 308348 | 1396086927 | K201775 | NuVision ICE Catheter | OBJ | 2021-03-05 |
| 308348 | 1457602595 | K201750 | Pentaray Nav eco High-Density Mapping Catheter | MTD | 2020-08-06 |
| 308348 | 1079351507 | K200484 | CARTO® 3 EP Navigation System with Signal Processing Unit | DQK | 2020-11-25 |
| 308348 | 1271511203 | K193632 | LassoStar Circular Mapping Catheter | DRF | 2020-06-30 |
| 308348 | 1124588025 | K193237 | Carto Octaray Mapping Catheter with Trueref Technology | MTD | 2020-07-31 |
| 308348 | 1724992981 | K191660 | CARTO 3 EP Navigation System, Version 7.1 and Accessories | DQK | 2019-07-20 |
| 308348 | 1272261028 | K180238 | CARTO 3 EP Navigation System, Version 6.0 and Accessories with VISITAG SURPOINT | DQK | 2018-06-01 |
| 314019 | 1272261028 | K180238 | CARTO 3 EP Navigation System, Version 6.0 and Accessories with VISITAG SURPOINT | DQK | 2018-06-01 |
| 308348 | 1436245044 | K173978 | CARTO 3 EP Navigation System, Version 5.2 and Accessories with CARTOFINDER Module | DQK | 2018-08-24 |
| 308348 | 1561419386 | K173977 | CARTO 3 EP Navigation System, Version 4.35 and Accessories with COHERENT MAP Module | DQK | 2018-06-14 |
| 314019 | 1561419386 | K173977 | CARTO 3 EP Navigation System, Version 4.35 and Accessories with COHERENT MAP Module | DQK | 2018-06-14 |
| 58743 | 1782306970 | K170997 | CARTO VIZIGO 8.5F Bi-Directional Guiding Sheath | DYB | 2017-07-25 |
| 308348 | 1782306970 | K170997 | CARTO VIZIGO 8.5F Bi-Directional Guiding Sheath | DYB | 2017-07-25 |
| 58743 | 1884929606 | K170600 | CARTO 3 EP Navigation System, Version 6.0 and Accessories | DQK | 2017-07-25 |
| 308348 | 1884929606 | K170600 | CARTO 3 EP Navigation System, Version 6.0 and Accessories | DQK | 2017-07-25 |
| 314019 | 1884929606 | K170600 | CARTO 3 EP Navigation System, Version 6.0 and Accessories | DQK | 2017-07-25 |
| 58743 | 1294293476 | K140318 | SOUNDSTAR ECO 8F GULTRASOUND CATHETER, SOUNDSTAR ECO 8F ULTRASOUND CATHETER | OBJ | 2014-03-12 |
| 308348 | 1294293476 | K140318 | SOUNDSTAR ECO 8F GULTRASOUND CATHETER, SOUNDSTAR ECO 8F ULTRASOUND CATHETER | OBJ | 2014-03-12 |
| 58743 | 2060908842 | K133916 | CARTO 3 EP NAVIGATION SYSTEM, VERSION 4.2 | DQK | 2014-07-01 |
| 58743 | 1107305348 | K132782 | CARTO3 EP NAVIGATION SYSTEM, VERSION 3.2 | DQK | 2014-01-24 |
| 58743 | 1220189289 | K130602 | LASSO NAV DUO LOOP CATHETER | DRF | 2013-08-14 |
| 308348 | 1220189289 | K130602 | LASSO NAV DUO LOOP CATHETER | DRF | 2013-08-14 |
| 58743 | 1365944363 | K123837 | PENTARAY NAV ECO HIGH-DENSITY MAPPING CATHETER | MTD | 2013-03-05 |
| 308348 | 1365944363 | K123837 | PENTARAY NAV ECO HIGH-DENSITY MAPPING CATHETER | MTD | 2013-03-05 |
| 58743 | 1513882560 | K120550 | CARTO(R) EP NAVIGATION SYSTEM, VERSION 3.0 (WITH STANDARD LOCATION PAD) | DQK | 2012-05-07 |
| 58743 | 1582213465 | K120425 | PENTARAY NAV HIGH-DENSITY MAPPING CATHETER | MTD | 2012-05-24 |
| 308348 | 1582213465 | K120425 | PENTARAY NAV HIGH-DENSITY MAPPING CATHETER | MTD | 2012-05-24 |
| 58743 | 1459095215 | K113213 | LASSO 2515 NAV ECO VARIABLE CATHETER LASSO NAV ECO CATHETER CONTINUED FROM LINE 2 | DRF | 2011-12-05 |
| 308348 | 1459095215 | K113213 | LASSO 2515 NAV ECO VARIABLE CATHETER LASSO NAV ECO CATHETER CONTINUED FROM LINE 2 | DRF | 2011-12-05 |
| 58743 | 1519836953 | K112050 | SOUNDSTAR ECO DIAGNOSTIC ULTRASOUND CATHETER | OBJ | 2011-11-18 |
| 308348 | 1519836953 | K112050 | SOUNDSTAR ECO DIAGNOSTIC ULTRASOUND CATHETER | OBJ | 2011-11-18 |
| 58743 | 1121636626 | K112007 | CARTO 3 EP NAVIGATION SYSTEM, VERSION 2.2 | DQK | 2011-10-05 |
| 58743 | 2059738201 | K101991 | WEBSTER DUO-DECAPOLAR CATHETER | DRF | 2011-05-02 |
| 308348 | 2059738201 | K101991 | WEBSTER DUO-DECAPOLAR CATHETER | DRF | 2011-05-02 |
| 308348 | 1759609951 | K101345 | WEBSTER CS CATHETER WITH EZ STEER TECHNOLOGY, WEBSTER CS CATHETER WITH EZ STEER TECHNOLOGY AND AUTO ID MODEL: D-1263-04, | DRF | 2010-06-22 |
| 58743 | 1436335805 | K101138 | SOUNDSTAR 3D ULTRASOUND CATHETER MODEL M-5723-12 | OBJ | 2010-06-22 |
| 308348 | 1436335805 | K101138 | SOUNDSTAR 3D ULTRASOUND CATHETER MODEL M-5723-12 | OBJ | 2010-06-22 |
| 308348 | 2002058817 | K093376 | LASSO NAV CATHETER | DRF | 2010-06-18 |
| 58743 | 1492436982 | K092064 | SOUNDSTAR 3D ULTRASOUND CATHETER, MODEL M-5723-12 | OBJ | 2009-08-07 |
| 308348 | 1492436982 | K092064 | SOUNDSTAR 3D ULTRASOUND CATHETER, MODEL M-5723-12 | OBJ | 2009-08-07 |
| 58743 | 1700768207 | K091352 | SOUNDSTAR 3D DIAGNOSTIC CATHETER, MODEL M-5723-05 | OBJ | 2009-12-04 |
BIOSENSE WEBSTER, INC.
BIOSENSE WEBSTER, INC.
BIOSENSE WEBSTER, INC.
BIOSENSE WEBSTER, INC.
BIOSENSE WEBSTER, INC.
BIOSENSE WEBSTER, INC.
BIOSENSE WEBSTER, INC.
BIOSENSE WEBSTER, INC.
BIOSENSE WEBSTER, INC.
BIOSENSE WEBSTER, INC.
BIOSENSE WEBSTER, INC.
BIOSENSE WEBSTER, INC.
BIOSENSE WEBSTER, INC.
BIOSENSE WEBSTER, INC.
BIOSENSE WEBSTER, INC.
BIOSENSE WEBSTER, INC.
BIOSENSE WEBSTER, INC.
BIOSENSE WEBSTER, INC.
BIOSENSE WEBSTER, INC.
BIOSENSE WEBSTER, INC.
BIOSENSE WEBSTER, INC.
BIOSENSE WEBSTER, INC.
BIOSENSE WEBSTER, INC.
BIOSENSE WEBSTER, INC.
BIOSENSE WEBSTER, INC.
BIOSENSE WEBSTER, INC.
BIOSENSE WEBSTER, INC.
BIOSENSE WEBSTER, INC.
BIOSENSE WEBSTER, INC.
BIOSENSE WEBSTER, INC.
BIOSENSE WEBSTER, INC.
BIOSENSE WEBSTER, INC.
BIOSENSE WEBSTER, INC.
BIOSENSE WEBSTER, INC.
BIOSENSE WEBSTER, INC.
BIOSENSE WEBSTER, INC.
BIOSENSE WEBSTER, INC.
BIOSENSE WEBSTER, INC.
BIOSENSE WEBSTER, INC.
BIOSENSE WEBSTER, INC.
Biosense Webster, Inc.
Biosense Webster, Inc.
Biosense Webster, Inc.
Biosense Webster, Inc.
Biosense Webster, Inc.
Biosense Webster, Inc.
Biosense Webster, Inc.
Biosense Webster, Inc.
Biosense Webster, Inc.
Biosense Webster, Inc.
Biosense Webster, Inc.
Biosense Webster, Inc.
Biosense Webster, Inc.
Biosense Webster, Inc.
Biosense Webster, Inc.
Biosense Webster, Inc.
Biosense Webster, Inc.
Biosense Webster, Inc.
Biosense Webster, Inc.
Biosense Webster, Inc.
Biosense Webster, Inc.
BIOSENSE WEBSTER, INC.
BIOSENSE WEBSTER, INC.
BIOSENSE WEBSTER, INC.
BIOSENSE WEBSTER, INC.
BIOSENSE WEBSTER, INC.
BIOSENSE WEBSTER, INC.
BIOSENSE WEBSTER, INC.
BIOSENSE WEBSTER, INC.
BIOSENSE WEBSTER, INC.
BIOSENSE WEBSTER, INC.
BIOSENSE WEBSTER, INC.
BIOSENSE WEBSTER, INC.
BIOSENSE WEBSTER, INC.
BIOSENSE WEBSTER, INC.
BIOSENSE WEBSTER, INC.
BIOSENSE WEBSTER, INC.
BIOSENSE WEBSTER, INC.
BIOSENSE WEBSTER, INC.
BIOSENSE WEBSTER, INC.