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Biosense Webster, Inc.

557 FDA 510(k) clearances · PMA applicant

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RecordFirmDate
Biosense Webster Cables, Celsius DS Catheter, Celsius FLTR, EZ Steer Nav DS Catheter, NaviStar DS Catheter, NaviStar RMT (P010068/S068)Biosense Webster, Inc.2021-09-22
Biosense Webster Cables, Celsius Catheter, Celsius FLTR, Deflectable Diagnostic/Ablation Catheter,EZ Steer Catheter, EZ (P950005/S083)Biosense Webster, Inc.2021-09-22
CELSIUS THERMOCOOL, THERMOCOOL SF, THERMOCOOL SMARTTOUCH SF, NAVISTAR THERMOCOOL, THERMOCOOL EZ STEER, and THERMOCOOL SM (P030031/S120)Biosense Webster, Inc.2021-09-22
EZ Steer ThermoCool Catheter, EZ Steer ThermoCool Nav Catheter, NaviStar RMT ThermoCool Catheter, NaviStar ThermoCool C (P040036/S086)Biosense Webster, Inc.2021-09-22
CELSIUS, NAVISTAR and EZ STEER (P010068/S065)Biosense Webster, Inc.2021-09-22
CELSIUS DS, NAVISTAR DS, EZ STEER DS and CELSIUS FLTR (P950005/S080)Biosense Webster, Inc.2021-09-22
Biosense Webster Cables, EZ Steer Nav Catheter, NaviStar Catheter, NaviStar RMT Catheter (P990025/S068)Biosense Webster, Inc.2021-09-22
THERMOCOOL SMARTTOUCH® Uni-Directional Navigation Catheter, THERMOCOOL SMARTTOUCH® Bi-Directional Navigation Catheter, T (P030031/S123)Biosense Webster, Inc.2021-09-07
THERMOCOOL SMARTTOUCH® Uni-Directional Navigation Catheter, THERMOCOOL SMARTTOUCH® Bi-Directional Navigation Catheter (P040036/S085)Biosense Webster, Inc.2021-09-07
EZ Steer ThemoCool Nav Bi-Directional Electrophysiology Catheter, Navistar ThermoCool Catheter, Navistar RMT ThermoCool, (P040036/S083)Biosense Webster, Inc.2021-07-09
Celsius ThermoCool Electrophysiology Catheter, EZ Steer ThermoCool Bi-Directional Electrophysiology Catheter, EZ Steer T (P030031/S121)Biosense Webster, Inc.2021-07-09
Celsius FLTR (Flutter) Catheter, Celsius Electrophysiology Catheter, Webster Electrophysiology Catheter EZ Steer DS Bi-D (P950005/S081)Biosense Webster, Inc.2021-07-09
Smartablate System Interface Cables (P990071/S050)Biosense Webster, Inc.2021-07-09
Celsius FLTR (Flutter) Catheter, EZ STEER NAV Bi-Directional and EZ STEER NAV DS Bi-Directional Diagnostic/Ablation Defl (P010068/S066)Biosense Webster, Inc.2021-07-09
Interface CABLES, Navistar Electrophysiology Catheter, EZ Steer Nav Bi-Directional Electrophysiology Catheter, Navistar (P990025/S066)Biosense Webster, Inc.2021-07-09
THERMOCOOL SMARTTOUCH SF Catheter (P030031/S118)Biosense Webster, Inc.2021-05-13
Biosense Webster Cables, EZ Steer Nav Catheter, NaviStar Catheter, NaviStar RMT Catheter (P990025/S063)Biosense Webster, Inc.2021-04-28
EZ Steer ThermoCool Catheter, EZ Steer ThermoCool Nav Catheter, NaviStar RMT ThermoCool Catheter, NaviStar ThermoCool Ca (P040036/S080)Biosense Webster, Inc.2021-04-28
Biosense Webster Cables, Celsius Catheter, Celsius RMT Catheter, Celsius FLTR, Deflectable Diagnostic/Ablation Catheter, (P950005/S078)Biosense Webster, Inc.2021-04-28
Biosense Webster Cables (P990071/S048)Biosense Webster, Inc.2021-04-28
Celsius RMT ThermoCool Catheter, Celsius ThermoCool Catheter, EZ Steer ThermoCool Catheter, EZ Steer ThermoCool Nav Cath (P030031/S116)Biosense Webster, Inc.2021-04-28
Biosense Webster Cables, Celsius DS Catheter, Celsius FLTR, EZ Steer Nav DS Catheter, NaviStar DS Catheter, NaviStar RMT (P010068/S063)Biosense Webster, Inc.2021-04-28
EZ STEER™DS, EZ STEER™NAV, EZ STEER™, EZ STEER™THERMOCOOL NAV (P030031/S117)Biosense Webster, Inc.2021-04-27
NAVISTAR™RMT THERMOCOOL, NAVISTAR™DS, EZ STEER™NAV DS (P990025/S064)Biosense Webster, Inc.2021-04-27
RMT THERMOCOOL, NAVISTAR™, NAVISTAR™RMT, NAVISTAR™THERMOCOOL (P010068/S064)Biosense Webster, Inc.2021-04-27
EZ STEER™THERMOCOOL, THERMOCOOL™SF NAV, THERMOCOOL™SF (P040036/S081)Biosense Webster, Inc.2021-04-27
CELSIUS™, CELSIUS™DS, CELSIUS™RMT, CELSIUS™THERMOCOOL, CELSIUS (P950005/S079)Biosense Webster, Inc.2021-04-27
THERMOCOOL™SMARTTOUCH, THERMOCOOL™SMARTTOUCH SF (P990071/S049)Biosense Webster, Inc.2021-04-27
Celsius Thermocool, EZ Steer Thermocool Non-Nav Bi-Directional, Celsius RMT Thermocool, Thermocool SF Bi-directional non (P030031/S114)Biosense Webster, Inc.2021-04-07
Celsius Thermocool, EZ Steer Thermocool Non-Nav Bi-Directional, Celsius RMT Thermocool, Thermocool SF Bi-directional non (P030031/S115)Biosense Webster, Inc.2021-04-07
Celsius, Celsius RMT, EZ Steer Bi-directional non nav (P950005/S077)Biosense Webster, Inc.2021-04-07
Navistar Thermocool, EZ Steer Thermocool Nav Bi- Directional, Navistar RMT Thermocool, Thermocool SF Nav Bi-directional, (P040036/S079)Biosense Webster, Inc.2021-04-07
Navistar DS, Celsius DS, EZ Steer DS Bi-directional non nav, EZ Steer Nav DS Bi-directional, Celsius FLTR Uni-directiona (P010068/S062)Biosense Webster, Inc.2021-04-07
Navistar, Navistar RMT, EZ Steer Nav Bi-directional (P990025/S062)Biosense Webster, Inc.2021-04-07
THERMOCOOL SMARTTOUCH SF Catheter (P030031/S109)Biosense Webster, Inc.2021-03-26
Thermocool Smarttouch (P040036/S078)Biosense Webster, Inc.2021-03-02
Thermocool Smarttouch SF (P030031/S113)Biosense Webster, Inc.2021-03-02
Thermocool SF NAV, Celsius Thermocool, EZ Steer Thermocool, EZ Steer Thermocool Bi-Directional, and Navistar Thermocool (P030031/S112)Biosense Webster, Inc.2021-02-02
Celsius Fluter, NavistarDS Diagnostic, Celsius DS, EZ Steer Nav DS (P010068/S061)Biosense Webster, Inc.2021-02-02
Navistar EP, EZ Steer Nav Bi-Directional (P990025/S061)Biosense Webster, Inc.2021-02-02
Celsius, Celsius Flutter, EZ Steer (P950005/S076)Biosense Webster, Inc.2021-02-02
EZ Steer Thermocool, EZ Steer Thermocool Bi-Directional, Navistar Thermocool (P040036/S077)Biosense Webster, Inc.2021-02-02
NaviStar THERMOCOOL Deflectable Diagnostic/Ablation Catheter (P030031/S102)Biosense Webster, Inc.2021-01-28
EZ Steer ThermoCool Nav Deflectable Diagnostic/Ablation Catheter (P040036/S070)Biosense Webster, Inc.2021-01-28
ThermoCool SmartTouch Catheters (P030031/S111)Biosense Webster, Inc.2021-01-22
ThermoCool SmartTouch SF Catheters (P040036/S076)Biosense Webster, Inc.2021-01-22
SmartAblate Irrigation Tubing Set (P990071/S045)Biosense Webster, Inc.2020-10-01
THERMOCOOL SMARTTOUCH® SF Catheter (P030031/S100)Biosense Webster, Inc.2020-09-30
EZ Steer Thermocool Nav Bi-Directional Electrophysiology Catheter (P990025/S060)Biosense Webster, Inc.2020-09-24
EZ Steer Thermocool Nav Bi-Directional Electrophysiology Catheter, EZ Steer Thermocool Bi-Directional Electrophysiology (P030031/S108)Biosense Webster, Inc.2020-09-24
EZ Steer NAV DS Bi-Directional Electrophysiology Catheter (P010068/S060)Biosense Webster, Inc.2020-09-24
EZ Steer DS Bi-Directional Electrophysiology Catheter, EZ Steer Bi-Directional Electrophysiology Catheter (P950005/S075)Biosense Webster, Inc.2020-09-24
nGEN Pump (P990071/S044)Biosense Webster, Inc.2020-07-17
THERMOCOOL SMARTTOUCH Bi-Directional Navigation Catheter and THERMOCOOL SMARTTOUCH Navigation Catheter (P040036/S075)Biosense Webster, Inc.2020-07-10
THERMOCOOL SMARTTOUCH SF Uni-Directional Navigation Catheter and THERMOCOOL SMARTTOUCH SF Bi-Directional Navigation Cath (P030031/S107)Biosense Webster, Inc.2020-07-10
Thermocool Smarttouch SF (P030031/S106)Biosense Webster, Inc.2020-06-26
Thermocool Smarttouch (P040036/S074)Biosense Webster, Inc.2020-06-26
THERMOCOOL SMARTTOUCH SF Uni-Directional Navigation Catheter, SF Bi-Directional Navigation (P030031/S105)Biosense Webster, Inc.2020-04-30
THERMOCOOL SMARTTOUCH Bi-Directional Navigation Catheter, Navigation Catheter (P040036/S073)Biosense Webster, Inc.2020-04-30
Biosense Webster Cables (P990071/S043)Biosense Webster, Inc.2020-04-16
Celsius DS Catheter, Celsius FLTR, EZ Steer Nav DS Catheter, NaviStar DS Catheter, NaviStar RMT DS Catheter, and Biosens (P010068/S059)Biosense Webster, Inc.2020-04-16
Celsius Catheter, Celsius RMT Catheter, Celsius FLTR, Deflectable Diagnostic/Ablation Catheter, EZ Steer Catheter, EZ St (P950005/S074)Biosense Webster, Inc.2020-04-16
EZ Steer ThermoCool Catheter, EZ Steer ThermoCool Nav Catheter, NaviStar RMT ThermoCool Catheter, NaviStar ThermoCool Ca (P040036/S072)Biosense Webster, Inc.2020-04-16
Celsius RMT ThermoCool Catheter, Celsius ThermoCool Catheter, EZ Steer ThermoCool Catheter, EZ Steer ThermoCool Nav Cath (P030031/S104)Biosense Webster, Inc.2020-04-16
EZ Steer Nav Catheter, NaviStar Catheter, NaviStar RMT Catheter, and Biosense Webster Cables (P990025/S059)Biosense Webster, Inc.2020-04-16
Thermocool Smarttouch Bi-Directional Navigation Catheter, Thermocool Smarttouch SF Uni-Directional Navigation Catheter, (P040036/S071)Biosense Webster, Inc.2020-03-31
Thermocool Smarttouch Bi-Directional Navigation Catheter, Thermocool Smarttouch SF Uni-Directional Navigation Catheter, (P030031/S103)Biosense Webster, Inc.2020-03-31
Navistar DS Electrophysiology Catheter (P010068/S058)Biosense Webster, Inc.2020-02-26
Navistar Electrophysiology Catheter (P990025/S058)Biosense Webster, Inc.2020-02-26
Celsius Electrophysiology Catheter, Deflectable Tip Electrophysiology Catheter, EZ Steer Bi-Directional Electrophysiolog (P950005/S073)Biosense Webster, Inc.2020-02-26
EZ Steer Thermocool Navigation, EZ Steer Thermocool Bi-Directional Catheter, Thermocool SF Nav Bi-Directional Catheter, (P030031/S101)Biosense Webster, Inc.2020-02-26
Thermocool Smart Touch Bi-Directional and Thermocool Smart Touch Electrophysiology (P040036/S069)Biosense Webster, Inc.2020-02-26
EZ Steer Thermocool NAV Catheter and Navistar Thermocool (P040036/S068)Biosense Webster, Inc.2019-08-02
Celsius Catheter (P950005/S072)Biosense Webster, Inc.2019-08-02
Celsius, EZ Steer, and Navistar Thermocool Catheter (P030031/S099)Biosense Webster, Inc.2019-08-02
CoolFlow Irrigation Tubing Set (P990071/S040)Biosense Webster, Inc.2019-05-08
ThermoCool SmartTouch SF Catheter (P040036/S065)Biosense Webster, Inc.2019-04-29
ThermoCool SmartTouch Catheter (P030031/S095)Biosense Webster, Inc.2019-04-29
SmartAblate Irrigation Pump, nGEN Pump Devices (P990071/S042)Biosense Webster, Inc.2019-04-29
ThermaCool SmartTouch SF Bi-directional and ThermoCool SmartTouch SF Uni-directional navigation Catheter (P030031/S097)Biosense Webster, Inc.2019-04-19
ThermoCool SmartTouch Uni-directional and ThermoCool SmartTouch Bi-directional navigation Catheter (P040036/S067)Biosense Webster, Inc.2019-04-19
Biosense Webster NaviStar Thermocool Catheter (P030031/S091)Biosense Webster, Inc.2019-04-12
Vistag Surpoint External Process Unit (EPU) (P030031/S092)Biosense Webster, Inc.2019-04-02
ThermoCool SmartTouch SF Bi-Directional Navigation Catheter; ThermoCool SmartTouch SF Uni-Directional Navigation Cathete (P040036/S064)Biosense Webster, Inc.2019-03-26
ThermoCool SmartTouch Bi-Directional Navigation Catheter; ThermoCool SmartTouch Uni-Directional Navigation Catheter (P030031/S094)Biosense Webster, Inc.2019-03-26
Celsius RMT Catheter; Navistar RMT Thermocool Catheter; Celsius RMT Thermocool Catheter; Navistar RMT Catheter (P950005/S071)Biosense Webster, Inc.2019-03-08
Navistar RMT Catheter (P990025/S057)Biosense Webster, Inc.2019-03-08
Navistar RMT Thermocool Catheter; Celsius Thermocool Catheter; Celsius RMT Thermocool Catheter (P030031/S096)Biosense Webster, Inc.2019-03-08
Navistar RMT Thermocool Catheter (P040036/S066)Biosense Webster, Inc.2019-03-08
THERMOCOOL SMARTTOUCH SF Uni/Bi-Directional Navigation Catheter (P030031/S093)Biosense Webster, Inc.2018-11-15
nGEN Pump (P990071/S037)Biosense Webster, Inc.2018-09-04
Celsius DS Electrophysiology Catheter (P010068/S057)Biosense Webster, Inc.2018-07-30
Smartablate Cable (P990071/S041)Biosense Webster, Inc.2018-07-30
Celsius ThermoCool Electrophysiology Catheter, Navistar RMT Thermocool and Celsius RMT THermocool (P030031/S089)Biosense Webster, Inc.2018-07-30
Navistar RMT Electrophysiology Catheter (P990025/S056)Biosense Webster, Inc.2018-07-30
Webster Electrophysiology Catheter, Celsius Electrophysiology Catheter, Electrophysiology Catheter Deflectable braided t (P950005/S070)Biosense Webster, Inc.2018-07-30
ThermoCool SmartTouch Uni-Bi-Directional Navigation Catheter (P040036/S063)Biosense Webster, Inc.2018-07-26
ThermoCool SmartTouch SF Catheters Uni/Bi-Directional Naviation Catheter (P030031/S090)Biosense Webster, Inc.2018-07-26
ThermoCool Smart Touch SF Bi-Directional Navigation Catheter & ThermoCool Smart Touch SF Uni-Direcional Navigation Cathe (P030031/S088)Biosense Webster, Inc.2018-07-18
SmartAblate System (P990071/S039)Biosense Webster, Inc.2018-06-15
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