ThermoCool SmartTouch
BIOSENSE WEBSTER, INC.
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 9673241 | 3003248396 | BIOSENSE WEBSTER, INC. | 1 | N | 2026-01-01 | CIRCUITO INTERIOR NORTE, No. 1820 PARQUE INDUSTRIAL SALVARCAR JUAREZ Chihuahua MX 32574 |
| 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 |
| 58745 | 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 |
| 58745 | 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 |
| 58745 | 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 |
| 58745 | 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 |
| 58745 | 1316897506 | P210027 | QDOT MICRO™ System | OAE | 2022-11-23 |
| 58742 | 1165329946 | P040036 | NAVISTAR THERMOCOOL DEFLECTABLE DIAGNOSTIC/ABLATION CATHETER | LPB | 2006-08-11 |
| 58745 | 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 |
| 58745 | 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 |
| 58745 | 1366746373 | P010068 | NAVISTAR/CELSIUS DS DIAGNOSTIC/ABLATION DEFLECTABLE 8MM TIP CATHETER | OAD | 2002-09-27 |
| 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 |
| 58745 | 1148648591 | K992965 | CORDIS WEBSTER FIXED CURVE CATHETERS, MODELS D-1124, D-1085 | DRF | 1999-11-26 |
| 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 |
| 58745 | 1367532919 | K991531 | CORDIS WEBSTER DIAGNOSTIC DEFLECTABLE TIP CATHETER, MODEL D-1078 | DRF | 1999-10-04 |
| 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 |
| 58745 | 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 |
| 58745 | 1063935976 | K982415 | CORDIS WEBSTER REF-STAR EXTERNAL REFERENCE PATCH, MODEL # D-1210 | DRF | 1998-08-10 |
| 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 |
| 58745 | 1078027235 | K980961 | CORDIS WEBSTER REF-STAR EX SURFACE REFERENCE DEVICE MODEL'S D-1204-01, -02,-03, AND -04. | DRF | 1998-05-28 |
| 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 |
| 58745 | 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 |
| 58745 | 1425029505 | K955817 | CORIDIS WEBSTER DEFLECTABLE BRAIDED-TIP ELECTRODE CATHETER | DRF | 1996-03-25 |
| 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 |
| 58745 | 1816500739 | K954390 | CORDIS WESTER STAR CATHETER | DRF | 1995-12-21 |
| 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 |
| 58745 | 1079815869 | K953768 | CORDIS WEBSTER A20 DIAGNOSTIC DEFLECTABLE TIP CATHETER | DRF | 1995-11-22 |
| 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 |
| 58745 | 1700098476 | K953663 | CORDIS WEBSTER T20 DIAGNOSTIC DEFLECTABLE TIP CATHETER | DRF | 1996-09-18 |
| 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 | |||
| 58745 | 1306939737 | K892265 | |||
| 308348 | 1306939737 | K892265 | |||
| 58745 | 1718281991 | K853383 | CARDIOVASCULAR, THERMODILUTION, FLOW, CORONARY SIN | DYG | 1985-12-03 |
| 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 |
| 58745 | 1373562806 | K841802 | ELECTRODE CATHETER, ORTHOGONAL TYPE | LDF | 1984-10-18 |
| 58742 | 1373562806 | K841802 | ELECTRODE CATHETER, ORTHOGONAL TYPE | LDF | 1984-10-18 |
| 58743 | 1373562806 | K841802 | ELECTRODE CATHETER, ORTHOGONAL TYPE | LDF | 1984-10-18 |
| 58745 | 1836872792 | K834602 | SWITCHING UNIT ELECTRODE CATHETER | DRF | 1984-05-09 |
| 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 |
| 58745 | 1999568673 | K241540 | NUVISION™ Ultrasound Catheter; NUVISION™ NAV Ultrasound Catheter | OBJ | 2024-06-28 |
| 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 |
| 58745 | 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 |
| 58745 | 1838273211 | K230253 | OPTRELL™ Mapping Catheter with TRUEref™ Technology | MTD | 2023-03-02 |
| 308348 | 1838273211 | K230253 | OPTRELL™ Mapping Catheter with TRUEref™ Technology | MTD | 2023-03-02 |
| 58745 | 2007244677 | K223766 | NUVISION™ NAV Ultrasound Catheter | OBJ | 2023-02-16 |
| 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 |
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.