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Biosense Webster, Inc.

557 FDA 510(k) clearances · PMA applicant

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RecordFirmDate
Visitag Surpoint External Processing Unit (EPU) (P030031/S086)Biosense Webster, Inc.2018-06-01
WEBSTER Catheter / CELSIUS Catheter (P950005/S069)Biosense Webster, Inc.2018-03-28
ThermoCool SmartTouch Uni-Directional Navigation Catheter (P040036/S060)Biosense Webster, Inc.2018-02-02
ThermoCool SmartTouch Bi-Directional Navigation Catheter (P030031/S082)Biosense Webster, Inc.2018-02-02
ThermoCool Smart Touch (P030031/S087)Biosense Webster, Inc.2018-01-11
ThermoCool Smart Touch SF Catheters (P040036/S062)Biosense Webster, Inc.2018-01-11
Biosense Webster NaviStar ThermoCool Catheter (P030031/S085)Biosense Webster, Inc.2018-01-05
Navi-Star Diagnostics/ Ablation Deflectable Tip Catheter (P990025/S052)Biosense Webster, Inc.2017-10-24
Webster Diag/ Ablation Deflectable Tip Catheter (P950005/S064)Biosense Webster, Inc.2017-10-24
Biosense Webster Navistar/Celsius Thermo Cool Diagnostic/Ablation Deflectable Tip Catheters (P030031/S080)Biosense Webster, Inc.2017-10-24
Navistar Thermocool Deflectable Diagnostics/Ablation Catheter (P040036/S058)Biosense Webster, Inc.2017-10-24
Navistar/Celsius DS Diagnostic/Ablation Deflectable 8MM Tip Catheter (P010068/S053)Biosense Webster, Inc.2017-10-24
Stockert 70 Radio Frequency Ablation Generator (P990071/S038)Biosense Webster, Inc.2017-10-17
Navistar Thermo Cool Deflectable Diagnostic/Ablation Catheter (P040036/S061)Biosense Webster, Inc.2017-10-17
Navistar/Celsius Thermo Cool Diagnostic/Ablation Deflectable Tip Catheters (P030031/S084)Biosense Webster, Inc.2017-10-17
Webster Diag./Ablation Deflectable Tip Catheter (P950005/S068)Biosense Webster, Inc.2017-10-17
Navi-Star Diagnostic/Ablation Deflectable Tip Catheter (P990025/S055)Biosense Webster, Inc.2017-10-17
Navistar/Celsius DS Diagnostic/Ablation Deflectable 8MM Tip Catheter (P010068/S056)Biosense Webster, Inc.2017-10-17
WEBSTER CATHETER, CELSIUS THERMOCOOL Catheter, CELSIUS Catheter (P950005/S067)Biosense Webster, Inc.2017-10-10
CELSIUS DS Catheter, NAVISTAR DS Catheter (P010068/S055)Biosense Webster, Inc.2017-10-10
NaviStar Catheter (P990025/S054)Biosense Webster, Inc.2017-10-10
CELSIUS THERMOCOOL Catheter (P030031/S083)Biosense Webster, Inc.2017-10-10
SmartAblate System Foot Pedal. (P990071/S036)Biosense Webster, Inc.2017-08-23
BIOSENSE WEBSTER CABLES (P990071/S034)Biosense Webster, Inc.2017-08-10
NAVI-STAR DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETER (P990025/S049)Biosense Webster, Inc.2017-08-10
BIOSENSE WEBSTER NAVISTAR/CELSIUS THERMO COOL DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETERS (P030031/S074)Biosense Webster, Inc.2017-08-10
NAVISTAR THERMOCOOL DEFLECTABLE DIAGNOSTIC/ABLATION CATHETER (P040036/S055)Biosense Webster, Inc.2017-08-10
NAVISTAR/CELSIUS DS DIAGNOSTIC/ABLATION DEFLECTABLE 8MM TIP CATHETER (P010068/S051)Biosense Webster, Inc.2017-08-10
WEBSTER DIAG./ABLATION DEFLECTABLE TIP CATHETER (P950005/S061)Biosense Webster, Inc.2017-08-10
EZ Steer Smart Touch; Thermocooll ST Uni (P040036/S059)Biosense Webster, Inc.2017-07-27
EZ Steer Navigational 4mm (TC) (P990025/S053)Biosense Webster, Inc.2017-07-27
EZ Steer Navigational 4mm; C3 EZ Steer Thermocool Nav; Ez Steer Thermocool Non-Navigational 4mm (TC); EZ Steer Thermocoo (P030031/S081)Biosense Webster, Inc.2017-07-27
EZ Steer Navigational 8mm (DS) ; Celsius FLTR Uni-Dir. (P010068/S054)Biosense Webster, Inc.2017-07-27
Therapeutic Catheters (P950005/S065)Biosense Webster, Inc.2017-07-27
EZ Steer Non- Navigational 8mm (DS) ; EZ Steer DS ; EZ Steer Non-Navigational 4mm (TC) & (THR) ; Celsius 4mm Bi-Dir T ; (P950005/S066)Biosense Webster, Inc.2017-07-27
WEBSTER CATHETER; CELSIUS THERMOCOOL CATHETER; CELSIUS CATHETER;; CELSIUS RMT CATHETER (P950005/S063)Biosense Webster, Inc.2017-07-17
NAVISTAR RMT; NAVISTAR RMT DS CATHETER (P990025/S051)Biosense Webster, Inc.2017-07-17
Stockert 70 RF Generator Foot Pedal (P990071/S035)Biosense Webster, Inc.2017-06-21
ThermoCool SmartTouch SF Bi-Directional & Uni-Directional Navigation Catheter's (P030031/S079)Biosense Webster, Inc.2016-11-22
The ThermoCool SmartTouch SF Uni-Directional & Bi-Directional Navigational Catheter (P030031/S078)Biosense Webster, Inc.2016-10-27
THERMOCOOL SMART TOUCH BI-DIRECTIONAL AND ELECTROPHYSIOLOGY (P040036/S057)Biosense Webster, Inc.2016-09-21
CELSIUS/DEFLECTABLE TIP ELECTROPHYSIOLOGY CATHETER (P950005/S062)Biosense Webster, Inc.2016-09-21
NAVISTAR DS ELECTROPHYSIOLOGY CATHETER (P010068/S052)Biosense Webster, Inc.2016-09-21
NAVISTAR ELECTROPHYSIOLOGY CATHETER (P990025/S050)Biosense Webster, Inc.2016-09-21
EZ STEER THERMOCOOL NAVIGATION AND THERMOCOOL BI-DIRECTIONAL CATHETER;THERMOCOOL SF/SF NAV BI-DIRECTIONAL AND SF/SF NAV (P030031/S077)Biosense Webster, Inc.2016-09-21
THERMOCOOL SMARTTOUCH SF BI-DIRECTIONAL & UNI-DIRECTIONAL NAVIGATION CATHETER (P030031/S076)Biosense Webster, Inc.2016-09-20
THERMOCOOL SMARTTOUCH SF UNI-DIRECTIONAL NAVIGATION CATHETER; THERMOCOOL SMARTTOUCH SF BI-DIRECTIONAL NAVIGATION CATHETE (P030031/S072)Biosense Webster, Inc.2016-08-11
SMARTABLATE SYSTEM: SMARTABLATE RF GENERATOR AND REMOTE CONTROL, SMARTABLATE SYSTEM: SMARTABLATE IRRIGATION PUMP (P990071/S033)Biosense Webster, Inc.2016-08-04
THERMOCOOL SMARTTOUCH BI-DIRECTIONAL NAVIGATION CATHETER (P040036/S056)Biosense Webster, Inc.2016-07-18
ThermoCool SmartTouch Uni-Directional Navigation Catheter (P030031/S075)Biosense Webster, Inc.2016-07-18
BIOSENSE WEBSTER NAVISTAR/CELSIUS THERMO COOL DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETERS (P030031/S073)Biosense Webster, Inc.2016-04-25
NAVISTAR DS CATHETER, EZ Steer Nav DS Bi-Directional Catheter (P010068/S050)Biosense Webster, Inc.2016-04-25
THERMOCOOL SMART TOUCH UNI-DIRECTIONAL NAVIGATION CATHETER (P040036/S054)Biosense Webster, Inc.2016-04-25
EZ Steer DS Bi-Directional Catheter,EZ Steer Bi-Directional CatheterABLATION, Celsius Flutter Bi-Directional Catheter (P950005/S060)Biosense Webster, Inc.2016-04-25
NAVI-STAR and EZ Steer Nav Bi-Directional Catheter (P990025/S048)Biosense Webster, Inc.2016-04-25
CELSIUS RMT THERMOCCOL CAT, CELSIUS THERMOCCOL CATH NAVISTAR & RMT THERMOCOOL CATHS,THERMOCOOL SF, SMARTTOUCH& NAV CATH (P030031/S059)Biosense Webster, Inc.2015-12-17
BIOSENSE WEBSTER CABLES (P990071/S028)Biosense Webster, Inc.2015-12-17
BIOSENSE WEBSTER CABLES, CELSIUS CATHETER, CELSIUS RMT CATHETER, CLESIUS FLTR, DEFLECTABLE DISGNOSTIC/ABLATION CATHETER (P950005/S051)Biosense Webster, Inc.2015-12-17
EZ STEER THERMOCOOL CATH, EZ STEER THERMOCOOL NAV CATH NAVISTAR RMT THERMOCOOL & THERMOCOOL CATH, THERMOCOOL SMARTTOUCH (P040036/S044)Biosense Webster, Inc.2015-12-17
BIOSENSE WEBSTER CABLES, CELSIUS DS CATHETER, CELSIUS FLTR, EZ STEER NAV DS CATH, NAVISTAR DS CATH, NAVISTAR RMT DS CATH (P010068/S040)Biosense Webster, Inc.2015-12-17
BIOSENSE WEBSTER CABLES, EZ STEER NAV CATHETER, NAVISTAR CATHETER, NAVISTAR RMT CATHETER (P990025/S040)Biosense Webster, Inc.2015-12-17
THERMOCOOL SMARTTOUCH (P040036/S053)Biosense Webster, Inc.2015-11-05
CELSIUS DS (P950005/S059)Biosense Webster, Inc.2015-11-05
NAVISTAR (P990025/S047)Biosense Webster, Inc.2015-11-05
CELSIUS THERMOCOOL, THERMOCOOL SF, NAVISTAR THERMOCOOL, THERMOCOOL SF NAV, THERMOCOOL SMARTTOUCH (P030031/S071)Biosense Webster, Inc.2015-11-05
CELSIUS, CELSIUS FLTR, NAVISTAR DS (P010068/S049)Biosense Webster, Inc.2015-11-05
STOCKERT 70 RADIOFREQUENCY ABLATION GENERATOR (P990071/S032)Biosense Webster, Inc.2015-09-16
THERMOCOOL SMARTTOUCH UNI-DIRECTIONAL NAVIGATION CATHETER (P030031/S070)Biosense Webster, Inc.2015-08-18
THERMOCOOL SMARTTOUCH BI-DIRECTIONAL NAVIGATION CATHETER (P040036/S052)Biosense Webster, Inc.2015-08-18
CELSIUS FLTR BI-DIRECTIONAL CATHETER (P010068/S048)Biosense Webster, Inc.2015-08-18
CELSIUS FLTR UNI -DIRECTIONAL CATHETER (P950005/S058)Biosense Webster, Inc.2015-08-18
THERMOCOOL SMARTTOUCH BI-DIRECTIONAL NAVIGATION CATHETER (P030031/S069)Biosense Webster, Inc.2015-08-06
THERMOCOOK SMARTTOUCH UNI-DIRECTIONAL NAVIGATION CATHETER (P040036/S051)Biosense Webster, Inc.2015-08-06
SMARTABLATE SYSTEM (P990071/S031)Biosense Webster, Inc.2015-06-16
CATHETER, PERCUTANEOUS, CARDIAC ABLATION CELSIUS THERMO-COOL ELECTROPHYSIOLOGY CATHETER (P030031/S068)Biosense Webster, Inc.2015-06-02
CATHETER, PERCUTANEOUS, CARDIAC ABLATION NAVISTAR ELECTROPHYSIOLOGY CATHETER (P990025/S046)Biosense Webster, Inc.2015-06-02
CATHETER, PERCUTANEOUS, CARDIAC ABLATION CELSIUS ELECTROPHYSIOLOGY CATHETER, (P950005/S057)Biosense Webster, Inc.2015-06-02
CATHETER, PERCUTANEOUS, CARDIAC ABLATION NAVISTAR DS ELECTROPHYSIOLOGY CATHETER (P010068/S047)Biosense Webster, Inc.2015-06-02
EZ STEER NAV DS (P010068/S046)Biosense Webster, Inc.2015-03-23
EZ STEER NAV (P990025/S045)Biosense Webster, Inc.2015-03-23
EZ STEER THERMOCOOL NAV, THERMOCOOL SF NAV (P030031/S067)Biosense Webster, Inc.2015-03-23
EZ STEER THERMOCOOL NAV (P040036/S050)Biosense Webster, Inc.2015-03-23
EZ STEER DS BI-DIRECTIONAL CATHETER, CELSIUS CATHETER (P950005/S056)Biosense Webster, Inc.2015-03-19
THERMOCOOL SMART TOUCH BI-DIRECTIONAL CATHETERS (P040036/S049)Biosense Webster, Inc.2015-03-19
EZ STEER NAV BI-DIRECTIONAL CATHETER AND NAVISTAR CATHETER (P990025/S044)Biosense Webster, Inc.2015-03-19
EZ STEER NAV DS BI-DIRECTIONAL CATHETERS (P010068/S045)Biosense Webster, Inc.2015-03-19
EZ STEER AND THERMOCOOL CATHETER FAMILIES (P030031/S066)Biosense Webster, Inc.2015-03-19
THERMOCOOL SMARTTOUCH BI-DIRECTIONAL NAVIGATIONAL CATHETER (P030031/S065)Biosense Webster, Inc.2015-03-18
THERMOCOOL SMARTTOUCH UNI-DIRECTIONAL NAVIGATIONAL CATHETER (P040036/S048)Biosense Webster, Inc.2015-03-18
SMARTABLATE SYSTEM (P990071/S030)Biosense Webster, Inc.2014-12-12
CELSIUS ELECTROPHYSIOLOGY CATHETER (P950005/S055)Biosense Webster, Inc.2014-12-08
NAVISTAR ELECTROPHYSIOLOGY CATHETER (P990025/S043)Biosense Webster, Inc.2014-12-08
NAVISTAR THERMOCOOL ELECTROPHYSIOLOGY CATHETER, CELSIUS THERMOCOOL ELECTROPHYSIOLOGY CATHETER (P030031/S064)Biosense Webster, Inc.2014-12-08
NAVISTAR DS ELECTROPHYSIOLOGY CATHETER (P010068/S044)Biosense Webster, Inc.2014-12-08
THERMOCOOL SMARTTOUCH BI-DIRECTIONAL NAVIGATION CATHETER AND THERMOCOOL SMARTTOUCH UNI-DIRECTIONAL NAVIGATION CATHETER (P030031/S063)Biosense Webster, Inc.2014-11-19
COOLFLOW IRRIGATION PUMP (P990071/S029)Biosense Webster, Inc.2014-11-19
THERMOCOOL SMARTTOUCH BI-DIRECTIONAL NAVIGATION CATHETER AND THERMOCOOL SMARTTOUCH UNI-DIRECTIONAL NAVIGATION CATHETER (P040036/S047)Biosense Webster, Inc.2014-11-19
NAVISTAR THERMOCOOL, NAVISTAR RMT THERMOCOOL, EZ STEER THERMOCOOL, THERMOCOOL ST (P040036/S046)Biosense Webster, Inc.2014-11-18
NAVISTAR THERMOCOOL, CELSIUS THERMOCOOL, NAVISTAR RMT THERMOCOOL, EZ STEER THERMOCOOL,CELSIUS RMT THERMOCOOL, THERMOCOOL (P030031/S062)Biosense Webster, Inc.2014-11-18
NAVISTAR DS, CELSIUS DS, EZ STEER NAV DS, NAVISTAR RMT DS, CELSIUS (P010068/S043)Biosense Webster, Inc.2014-11-18
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