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Biosense Webster, Inc.

557 FDA 510(k) clearances · PMA applicant

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RecordFirmDate
NAVISTAR 4MM, NAVISTAR RMT 4MM, EZ STEER 4MM NAV (P990025/S042)Biosense Webster, Inc.2014-11-18
CELSIUS FLUTTERS, CELSIUS, CELSIUS RMT, EZ STEER 4MM NON-NAV, EZ STEER DS, CELSIUS FLUTTERS (P950005/S054)Biosense Webster, Inc.2014-11-18
NAVI-STAR RMT DS ELECTROPHYSIOLOGY CATHETER (P010068/S042)Biosense Webster, Inc.2014-10-21
NAVI-STAR RMT ELECTROPHYSIOLOGY CATHETER (P990025/S041)Biosense Webster, Inc.2014-10-21
CELSIUS ELECTROPHYSIOLOGY CATHETER (P950005/S053)Biosense Webster, Inc.2014-10-21
THERMO-COOL SF (BI-DIRECTIONAL AND UNI-DIRECTIONAL ) CATHETERS (P030031/S061)Biosense Webster, Inc.2014-10-15
CELSIUS FLTR UNI-DIRECTIONAL CATHETER (P950005/S052)Biosense Webster, Inc.2014-09-12
THERMOCOOL SMARTTOUCH BI-DIRECTIONAL NAVIGATION CATHETER (P040036/S045)Biosense Webster, Inc.2014-09-12
CELSIUS FLTR BI-DIRECTIONAL CATHETER (P010068/S041)Biosense Webster, Inc.2014-09-12
THERMOCOOL SMARTTOUCH UNI-DIRECTIONAL NAVIGATION CATHETER (P030031/S060)Biosense Webster, Inc.2014-09-12
NAVISTAR THERMOCOOL (P040036/S043)Biosense Webster, Inc.2014-08-01
SMARTABLATE SYSTEM (FORMERLY STOCKERT 70 SYSTEM FOR CARDIAC ABLATION) (P990071/S027)Biosense Webster, Inc.2014-07-02
CELSIUS CATHETER, CELSIUS RMT CATHETER (P950005/S050)Biosense Webster, Inc.2014-07-02
CELSIUS DS CATHETER, NAVISTAR DS CATHETER (P010068/S039)Biosense Webster, Inc.2014-07-02
NAVISTAR RMT THERMOCOOL, D-1266-XX, CELSIUS RMT THERMOCOOL D-1302 XX (P030031/S044)Biosense Webster, Inc.2014-07-01
NAVISTAR RMT THERMOCOOL CATHETER (P040036/S032)Biosense Webster, Inc.2014-07-01
THERMOCOOL SMARTTOUCH BI-DIRECTIONAL NAVIGATION CATHETER,THERMOCOOL SMARTTOUCH UNI-DIRECTIONAL NAVIGATION CATHETER,THERM (P040036/S037)Biosense Webster, Inc.2014-02-11
THERMOCOOL SMARTTOUCH BI-DIRECTIONAL NAVIGATION CATHETER,THERMOCOOL SMARTTOUCH UNI-DIRECTIONAL NAVIGATION CATHETER,THERM (P030031/S053)Biosense Webster, Inc.2014-02-11
NAVISTAR THERMOCOOL CATHETER,NAVISTAR RMT THERMOCOOL CATHETER,EZ STEER THERMOCOOL CATHETER,EZ STEER THERMOCOOL NAV CATH (P040036/S041)Biosense Webster, Inc.2014-01-24
NAVISTAR ,NAVISTAR RMT ,EZ STEER NAV CATHETERS AND,BIOSENSE WEBSTER CABLES (P990025/S039)Biosense Webster, Inc.2014-01-24
NAVISTAR RMT DS ,EZ STEER NAV DS ,CELSIUS FLTR, CELSIUS DS, & NAVISTAR DS CATHETERS (P010068/S038)Biosense Webster, Inc.2014-01-24
CELSIUS CATHETER,CELSIUS RMT CATHETER,EZ STEER CATHETER,EZ STEER DS CATHETER, DEFLECTABLE DIAGNOSTIC/ABLATION CATHETERS, (P950005/S049)Biosense Webster, Inc.2014-01-24
CELCIUS/ RMT THERMOCOOL ,NAVISTAR THERMOCOOL ,NAVISTAR RMT THERMOCOOL, THERMOCOOL, EZ STEER THERMOCOOL SF CATHETERS (P030031/S058)Biosense Webster, Inc.2014-01-24
BIOSENSE WEBSTER CABLES (P990071/S025)Biosense Webster, Inc.2014-01-24
CELSIUS FLTR CATHETER UNIDIRECTIONAL, CELSIUS FLTR CATHETER BIDIRECTIONAL (P950005/S047)Biosense Webster, Inc.2014-01-22
CELSIUS FLTR CATHER UNIDIRECTIONAL,CELSIUS FLTR CATHETER BIDIRECTIONAL (P010068/S036)Biosense Webster, Inc.2014-01-22
CELSIUS FLTR CATHETERS (P010068/S037)Biosense Webster, Inc.2013-11-26
BIOSENSE WEBSTER CELSIUS FLTR CATHETER (P950005/S048)Biosense Webster, Inc.2013-11-26
NAVISTAR THERMOCOOL, NAVISTAR RMT THERMOCOOL, EZ STEER THERMOCOOL, CELSIUS RMT THERMOCOOL (P950005/S046)Biosense Webster, Inc.2013-10-09
THERMOCOOL SF (P040036/S040)Biosense Webster, Inc.2013-10-09
EZ STEER (P030031/S057)Biosense Webster, Inc.2013-10-09
NAVISTAR RMT CATHETER,EZ STEER NAV CATHETER,BIOSENSE WEBSTER CABLES (P990025/S038)Biosense Webster, Inc.2013-09-05
CELSIUS CATHETER,CELSIUS RMT CATHETER,EZ STEER CATHETER,,EZ STEER DS CATHETER (P950005/S045)Biosense Webster, Inc.2013-09-05
BIOSENSE WEBSTER CABLES (P990071/S024)Biosense Webster, Inc.2013-09-05
NAVISTAR THERMOCOOL CATHETER,NAVISTAR RMT THERMOCOOL CATHETER,EZ STEER THERMOCOOL CATHETER,EZ STEER THERMOCOOL NAV CATHE (P040036/S039)Biosense Webster, Inc.2013-09-05
CELCIUS DS CATHETER,NAVISTAR DS CATHETER,NAVISTAR RMT DS CATHETER,EZ STEER NAV DS CATHETER, (P010068/S035)Biosense Webster, Inc.2013-09-05
CELCIUS THERMOCOOL CATHETER,CELCIUS RMT THERMOCOOL CATHETER,NAVISTAR THERMOCOOL CATHETER,NAVISTAR RMT THERMOCOOL CATHETE (P030031/S055)Biosense Webster, Inc.2013-09-05
EZ STEER THERMOCOOL NAV (P040036/S038)Biosense Webster, Inc.2013-08-22
NAVISTAR THERMOCOOL (P030031/S054)Biosense Webster, Inc.2013-08-22
CELSIUS CATHETER, CELSIUS RMT CATHETER, EZ STEER DS CATHETER, DEFLECTABLE DIAGNOSTIC/ABLATION (P950005/S042)Biosense Webster, Inc.2013-07-22
NAVISTAR CATHETER, NAVISTAR RMT CATHETER, EZ STEER NAY CATHETER, BIOSENSE WEBSTER CABLES (P990025/S035)Biosense Webster, Inc.2013-07-22
NAVISTAR THERMOCOOL CATHETER, NAVISTAR RMT THERMOCOOL CATHETER, EZ STEER (P040036/S033)Biosense Webster, Inc.2013-07-22
CELSIUS DS CATHETER, NAVISTAR DS CATHETER, NAVISTAR RMT DS CATHETER, EZ STEER NAY DS (P010068/S032)Biosense Webster, Inc.2013-07-22
CELSIUS THERMOCOOL CATHETER, CELSIUS RMT THERMOCOOL CATHETER, CELSIUS RMT THERMOCOOL (P030031/S050)Biosense Webster, Inc.2013-07-22
SMARTABLATE SYSTEM-SMARTABLATE IRRIGATION PUMP KIT (P990071/S023)Biosense Webster, Inc.2013-07-17
BI-DIRECTIONAL CELSIUS FLTR CATHETERS (D-1359-XX-S) (P950005/S041)Biosense Webster, Inc.2013-06-06
UNI-DIRECTIONAL CELSIUS FLTR CATHETERS (D-1355-XX S) (P010068/S031)Biosense Webster, Inc.2013-06-06
EZ STEER BI-DIRECTIONAL NON NAV 4 MM TIP WITH THERMOCOUPLE, 7F EZ NON-NAV CATHETER W/4MM TIP ELECTRODE AND THERMISTOR (P950005/S044)Biosense Webster, Inc.2013-05-29
7.5 FR NAVI-STAR THERMO-COOL VATHETER WITH THERMISTOR (P040036/S036)Biosense Webster, Inc.2013-05-29
7F EZ STEER DS BI-DIRECTIONAL NAV CATHETER 4MM TIP ELECTRODE AND THERMOCOUPLE (P990025/S037)Biosense Webster, Inc.2013-05-29
7F CELCIUS THERMO-COOL CATHETER WITH THERMOCOUPLEM, 7F CELCIUS THERMOCOOL CATHETER WITH THERMMISTOR (P030031/S052)Biosense Webster, Inc.2013-05-29
7 FR EZ STEER NAV DS BI-DIRECTIONAL W/ 8MM TIP ELECTRODE W/ DUAL THERMOCOUPLE (P010068/S034)Biosense Webster, Inc.2013-05-29
CELCIUS DS CATHETER, NAVISTAR DS CATHETER, NAVISTAR RMT DS CATHETER, EZ STEER NAV DS CATHETER (P010068/S033)Biosense Webster, Inc.2013-04-25
BIOSENSE WEBSTER CABLES (P990071/S022)Biosense Webster, Inc.2013-04-25
NAVISTAR THERMOCOOL CATHETER,NAVISTAR RMT THERMOCOOL,EZ STEER THERMOCOOL CATHETER,EZ STEER THERMOCOOL NAV CATHETER (P040036/S035)Biosense Webster, Inc.2013-04-25
CELCIUS CATHETER,CELCIUS RMT CATHETER,EZ STEER CATHETER,EZ STEER DS CATHETER,DEFLECTABLE DIAGNOSTIC/ABLATION CATHETERS,B (P950005/S043)Biosense Webster, Inc.2013-04-25
CELCIUS THERMOCOOL CATHETER, CELCIUS RMT THERMOCOOL CATHETER,NAVISTAR THERMOCOOL CATHETER,NAVISTAR RMT THERMOCOOL (P030031/S051)Biosense Webster, Inc.2013-04-25
NAVISTAR CATHETER,NAVISTAR RMT CATHETER,EZ STEER NAV CATHETER,BIOSENSE WEBSTER CABLES (P990025/S036)Biosense Webster, Inc.2013-04-25
THERMOCOOL SF CATHETERS (P990071/S018)Biosense Webster, Inc.2013-04-12
CELSIUS DS, NAVISTAR DS,NAVISTAR RMT DS, EZ STEER NAV DS CATHETERS (P010068/S028)Biosense Webster, Inc.2013-04-12
CELSIUS THERMOCOOL, CELSIUS RMT THERMOCOOL, NAVISTAR THERMOCOOL, NAVISTAR RMT THERMOCOOL CATHETERS (P030031/S042)Biosense Webster, Inc.2013-04-12
CELSIUS, CELSIUS RMT, EZ STEER, EZ STEER DS CATHETERS (P950005/S038)Biosense Webster, Inc.2013-04-12
NAVISTAR, NAVISTAR RMT, EZ STEER NAV CATHETERS (P990025/S032)Biosense Webster, Inc.2013-04-12
NAVISTAR THERMOCOOL, NAVISTAR RMT THERMOCOOL, EZ STEER THERMOCOOL, EZ STEER THERMOCOOL NAV CATHETERS (P040036/S031)Biosense Webster, Inc.2013-04-12
NAVISTAR®THERMOCOOL® DIAGNOSTIC/ABLATION CATHETER (P040036/S030)Biosense Webster, Inc.2013-03-07
STOCKERT 70 RADIOFREQUENCY GENERATOR (P990071/S017)Biosense Webster, Inc.2013-03-07
NAVISTAR DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETER (P990025/S031)Biosense Webster, Inc.2013-03-07
NAVISTAR® THERMOCOOL® DIAGNOSTIC/ABLATION CATHETER AND CELSIUS® THERMOCOOL® DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETER (P030031/S041)Biosense Webster, Inc.2013-03-07
CELSIUS DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETER (P950005/S037)Biosense Webster, Inc.2013-03-07
NAVISTAR® AND CELSIUS® DS DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETERS (P010068/S027)Biosense Webster, Inc.2013-03-07
STOCKERT 70 RADIOFREQUENCY GENERATOR FOR CARDIAC ABLATION (P990071/S020)Biosense Webster, Inc.2012-11-20
STOCKERT 70 RADIOFREQUENCY GENERATOR FOR CARDIAC ABLATION (P990071/S016)Biosense Webster, Inc.2012-10-31
CELSIUS DS CATHETER AND NAVI-STAR DS CATHETER (P010068/S030)Biosense Webster, Inc.2012-10-24
CELSIUS CATHETERS (P950005/S040)Biosense Webster, Inc.2012-10-24
NAVI-STAR CATHETERS (P990025/S034)Biosense Webster, Inc.2012-10-24
CELSIUS THERMOCOOL CATHETERS (P030031/S048)Biosense Webster, Inc.2012-10-24
UNIDIRECTIONAL THERMOCOOL SF NAV CATHETER (P030031/S045)Biosense Webster, Inc.2012-10-02
THERMOCOOL SF CATHETERS (BI-DIRECTIONAL), THERMOCOOL SF CATHETERS (UNI-DIRECTIONAL) (P030031/S047)Biosense Webster, Inc.2012-09-20
CELSIUS DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETER (P950005/S039)Biosense Webster, Inc.2012-07-25
STOCKERT RADIOFREQUENCY GENERATOR (P990071/S019)Biosense Webster, Inc.2012-07-25
NAVISTAR DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETER (P990025/S033)Biosense Webster, Inc.2012-07-25
NAVISTAR/CELSIUS DS CATHETERS (P010068/S029)Biosense Webster, Inc.2012-07-25
CELSIUS THERMOCOOL CATHETER (P030031/S043)Biosense Webster, Inc.2012-07-23
THERMOCOOL SF BI-DIRECTIONAL AND UNI-DIRECTIONAL CATHETERS (P030031/S039)Biosense Webster, Inc.2012-06-15
EZ STEER THERMOCOOL NAV CATHETER, NAVI-STAR ELECTROPHYSIOLOGY CATHETER (P040036/S029)Biosense Webster, Inc.2012-03-30
EZ STEER THERMOCOOL NAV CATHETER, NAVI-STAR ELECTROPHYSIOLOGY CATHETER & THERMOCOOL SF NAV CATHETER (P030031/S040)Biosense Webster, Inc.2012-03-30
EZ STEER NAV ELECTROPHYSIOLOGY CATHETER (P990025/S030)Biosense Webster, Inc.2012-03-30
NAVISTAR DS ELECTROPHYSIOLOGY CATHETER (P010068/S026)Biosense Webster, Inc.2012-03-30
THERMACOOL SF BI-DIRECTIONAL AND UNI-DIRECTIONAL CATHETERS (P030031/S038)Biosense Webster, Inc.2012-03-23
CELSIUS/CELSIUS II DIAGNOSTIC/ABLATION DEFLECTABLE 4MM TIP CATHETERS/CELSIUS RMT DIAGNOSTIC/ABLATION STEERABLE TIP (P950005/S033)Biosense Webster, Inc.2012-02-08
NAVISTAR, CELSIUS, QWIKSTAR, EZ STEER BI-DIRECTIONAL, NAVISTAR RMT DUAL SENOR (8MM) DIAGNOSTIC/ABLATION DEFLECTABLE (P010068/S023)Biosense Webster, Inc.2012-02-08
NAVISTAR RMT THERMOCOOL CATHETER (P040036/S024)Biosense Webster, Inc.2012-01-13
NAVISTAR RMT THERMOCOOL CATHETER (P030031/S033)Biosense Webster, Inc.2012-01-13
CELSIUS/CELSIUS RMT/EZ STEER/EZ STEER DS/NON-TEMPERATURE SENSING ABLATION CATHETERS/INTERFACE CABLES (P950005/S036)Biosense Webster, Inc.2011-12-23
CELSIUS RMT THERMOCOOL MAGNETIC CATHETER (P040036/S028)Biosense Webster, Inc.2011-12-23
NAVISTAR RMT THERMOCOOL MAGNETIC STEERING CATHETERS (P030031/S037)Biosense Webster, Inc.2011-12-23
THERMOCOOL SF NAV BI-DIRECTIONAL CATHETER (D-1313-XX-S, D-1317-XX-S) AND THERMOCOOL SF BI-DIRECTIONAL CATHETER (P030031/S025)Biosense Webster, Inc.2011-12-21
THERMOCOOL SF NAV BI-DIRECTIONAL CATHETER (D1313-XX-S, D-1317-XX-S) AND THERMOCOOL SF BI-DIRECTIONAL CATHETER (P990071/S009)Biosense Webster, Inc.2011-12-21
THERMOCOOL SF NAV UNI-DIRECTIONAL CATHETER (D-1315-XX-S, D-1318-XX-S) AND THERMOCOOL SF UNI-DIRECTIONAL CATHETER (P990071/S013)Biosense Webster, Inc.2011-12-21
THERMOCOOL SF NAV UNI-DIRECTIONAL CATHETER (D-1315-XX-S, D-1318-XX-S) AND THERMOCOOL SF UNI-DIRECTIONAL CATHETER (P030031/S034)Biosense Webster, Inc.2011-12-21
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