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Irvine Biomedical,Inc.(Ibi)

57 FDA 510(k) clearances · PMA applicant

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RecordFirmDate
Safire TX Ablation Catheter; Safire TX, Catheter Extension Cable; Therapy 8mm Tip Thermistor Ablation Catheter; Therapy (P040042/S057)Irvine Biomedical,Inc.(Ibi)2025-04-10
Safire™ TX Ablation Catheter, Safire™ TX, Catheter Extension Cable, Therapy™ Dual-8™ Ablation Catheter, Cables 16- 17- 1 (P040042/S056)Irvine Biomedical,Inc.(Ibi)2024-10-15
Ampere™ Generator, Ampere™ Remote Control, Ampere™ Generator System Kit (P040042/S055)Irvine Biomedical,Inc.(Ibi)2023-11-29
Safire TX Ablation Catheter, Therapy Dual-8 Ablation Catheter, Safire TX, Catheter Extension Cable (P040042/S053)Irvine Biomedical,Inc.(Ibi)2022-12-16
Safire Ablation Catheter (P040042/S054)Irvine Biomedical,Inc.(Ibi)2022-12-08
Safire TX Ablation Catheter, Therapy Dual-8 Ablation Catheter, Safire TX, Catheter Extension Cable (P040042/S052)Irvine Biomedical,Inc.(Ibi)2022-11-15
Ampere™ Generator (P040042/S051)Irvine Biomedical,Inc.(Ibi)2021-10-14
Safire TX Ablation Catheter, Therapy Dual 8 Ablation Catheter, Therapy 8MM Thermistor Ablation Catheter (P040042/S050)Irvine Biomedical,Inc.(Ibi)2021-05-04
Therapy and Therapy Dual-8 and Safire TX Ablation Catheter (P040042/S049)Irvine Biomedical,Inc.(Ibi)2021-03-24
Therapy Cool Path, Safire BLU, Safire BLU SP, and Therapy Cool Path SP Ablation Catheters (P040042/S048)Irvine Biomedical,Inc.(Ibi)2021-03-12
Therapy Cool Path, Safire BLU, Safire BLU SP, and Therapy Cool Path SP Ablation Catheters (P040042/S046)Irvine Biomedical,Inc.(Ibi)2020-11-02
Therapy Dual 8 and Therapy 8mm Tip Thermistor Ablation Catheter (P040042/S047)Irvine Biomedical,Inc.(Ibi)2020-10-16
Therapy Dual-8 Ablation Catheter, Therapy 8mm Thermistor Ablation Catheter and Safire TX Ablation Catheter (P040042/S045)Irvine Biomedical,Inc.(Ibi)2020-04-24
Therapy Dual 8 Ablation Catheter and Therapy 8mm Thermistor Ablation Catheter (P040042/S044)Irvine Biomedical,Inc.(Ibi)2020-03-04
Therapy Dual-8, Therapy 8mm Thermistor, Safire TX Ablation Catheter (P040042/S043)Irvine Biomedical,Inc.(Ibi)2019-08-28
Electrophysiology Cable; SE-Safire TX, Catheter Extension Cable; Therapy 8mm, Thermistor, Dual 8, Safire TX Ablation Cat (P040042/S042)Irvine Biomedical,Inc.(Ibi)2019-04-11
Therapy Dual 8, Therapy 8mm Thermistor, Safire TX Ablation Catheters, 1500T6 RF Generators, 1500T9 RF Generators (P040042/S041)Irvine Biomedical,Inc.(Ibi)2019-01-10
Therapy Dual 8, Therapy 8mm Thermistor, Safire TX Ablation Catheters, 1500T6 RF Generators, 1500T9 RF Generators (P040042/S040)Irvine Biomedical,Inc.(Ibi)2018-03-06
Therapy Dual-8 Ablation Catheter, Therapy 8mm Thermistor Ablation Catheter, Safire TX Ablation Catheter (P040042/S037)Irvine Biomedical,Inc.(Ibi)2017-05-19
Therapy Dual 8 Ablation Catheters (P040042/S036)Irvine Biomedical,Inc.(Ibi)2016-09-08
THERAPY DUAL 8 THERAPY 8MM THERMISTER ABLATION CATHETER, SAFIRE TX BI-DIRECTIONAL ABLATION CATHETER (P040042/S035)Irvine Biomedical,Inc.(Ibi)2016-06-24
THERAPY DUAL 8 CATHETER,THERAPY 8MM THERMISTOR ABLATION CATHETER, SAFIRE TX, AND ASSOCIATED CABLES (P040042/S031)Irvine Biomedical,Inc.(Ibi)2016-04-29
THERAPY DUAL 8 CARDIAC ABLATION SYSTEM,THERAM 8MM THERMISTER ABLATION CATHETER SAFIRE TX ABLATION CATHETER (P040042/S034)Irvine Biomedical,Inc.(Ibi)2016-02-29
THERAPY DUAL 8, THERAPY 8MM THERMISTOR, AND SAFIRE TX ABLATION CATHETERS, AND 1500T6 AND 1500T9 RF GENERATOR (P040042/S033)Irvine Biomedical,Inc.(Ibi)2016-02-18
THERAPY COOL PATH, SAFIRE BLU, SAFIRE BLU SP, AND THERAPY COOL PATH SP ABLATION CATHETERS (P040042/S032)Irvine Biomedical,Inc.(Ibi)2015-10-21
THERAPY DUAL ABLATION CATHETER, SAFIRE TX ABLATION CATHETER (P040042/S029)Irvine Biomedical,Inc.(Ibi)2015-07-09
THERAPY DUAL 8 ABLATION CATHETER, THERAPY 8 MM THERMISTOR , SAFIRE TX ABLATION CATHETERS & GENERATORS (P040042/S030)Irvine Biomedical,Inc.(Ibi)2015-05-20
THERAPY DUAL 8 CATHETER (P040042/S028)Irvine Biomedical,Inc.(Ibi)2015-04-09
THERAPY DUAL 8 CATHETER (NON-IRRIGATED), THERAPY 8MM THERMISTOR ABLATION CATHERER (NON-IRRIGATED) SAFIRE TX CATHETER (NO (P040042/S027)Irvine Biomedical,Inc.(Ibi)2014-04-28
THERAPY DUAL 8 CATHETER (NON-IRRIGATED), THERAPY 8MM THERMISTOR ABLATION CATHETER (NON-IRRIGATED), SAFIRE TX CATHETER (P040042/S026)Irvine Biomedical,Inc.(Ibi)2014-03-21
THERAPY DUAL 8 ABLATION CATHETERS (P040042/S025)Irvine Biomedical,Inc.(Ibi)2013-09-27
THERAPY DUAL 8 CARDIAC ABLATION SYSTEM (P040042/S024)Irvine Biomedical,Inc.(Ibi)2012-08-22
THERAPY DUAL 8 CARDIAC ABLATION SYSTEM (P040042/S023)Irvine Biomedical,Inc.(Ibi)2011-11-10
THERAPY DUAL 8/THERAPY 8MM THERMISTOR/SAFIRE TX ABLATION CATHETERS (P040042/S022)Irvine Biomedical,Inc.(Ibi)2011-06-06
THERAPY DUAL 8/THERAPY 8MM THERMISTOR/SAFIRE TX ABLATION CATHETERS (P040042/S021)Irvine Biomedical,Inc.(Ibi)2011-02-17
THERAPY DUAL 8 ABLATION CATHETER (P040042/S020)Irvine Biomedical,Inc.(Ibi)2011-01-11
THERAPY DUAL 8/THERAPY 8MM THERMISTOR/SAFIRE TX ABLATION CATHETERS (P040042/S018)Irvine Biomedical,Inc.(Ibi)2010-03-23
THERAPY DUAL 8/THERAPY & SAFIRE TX ABLATION CATHETERS (P040042/S017)Irvine Biomedical,Inc.(Ibi)2010-01-12
THERAPY DUAL 8/THERAPY & SAFIRE TX ABLATION CATHETERS (P040042/S016)Irvine Biomedical,Inc.(Ibi)2009-08-28
THERAPY DUAL 8/THERAPY & SAFIRE TX ABLATION CATHETERS (P040042/S013)Irvine Biomedical,Inc.(Ibi)2009-06-17
THERAPY DUAL 8 ABLATION CATHETERS (P040042/S015)Irvine Biomedical,Inc.(Ibi)2009-06-01
THERAPY DUAL 8 ABLATION CATHETERS (P040042/S014)Irvine Biomedical,Inc.(Ibi)2008-12-10
THERAPY DUAL 8, THERAPY & SAFIRE TX ABLATION CATHETERS (P040042/S012)Irvine Biomedical,Inc.(Ibi)2008-06-09
SAFIRE TX CATHETER (P040042/S011)Irvine Biomedical,Inc.(Ibi)2007-10-19
SAFIRE TX CARDIAC ABLATION CATHETER AND INTERFACE CABLES (P040042/S009)Irvine Biomedical,Inc.(Ibi)2007-08-21
THERAPY DUAL 8 CARDIAC ABLATION SYSTEM (P040042/S007)Irvine Biomedical,Inc.(Ibi)2007-07-13
IBI THERAPY DUAL 8 ABLATION CATHETERS (P040042/S010)Irvine Biomedical,Inc.(Ibi)2007-04-13
THERAPY DUAL 8 ABLATION CATHETER & IBI-1500T6 CARDIAC ABLATION GENERATOR (P040042/S008)Irvine Biomedical,Inc.(Ibi)2007-03-16
THERAPY DUAL 8 CATHETER AND IBI-1500T6 CARDIAC ABLATION GENERATOR (P040042/S006)Irvine Biomedical,Inc.(Ibi)2007-01-10
THERAPY DUAL CATHETER AND IBI-1500T6 CARDIAC ABLATION GENERATOR (P040042/S005)Irvine Biomedical,Inc.(Ibi)2006-10-03
THERAPY DUAL 8 CATHETER AND IBI-1500T6 CARDIAC ABLATION GENERATOR (P040042/S004)Irvine Biomedical,Inc.(Ibi)2006-09-20
THERAPY DUAL 8 CATHETER AND IBI-1500T6 CARDIAC ABLATION GENERATOR (P040042/S003)Irvine Biomedical,Inc.(Ibi)2006-07-20
THERAPY DUAL 8 CATHETER AND IBI-1500T6 CARDIAC ABLATION GENERATOR (P040042/S002)Irvine Biomedical,Inc.(Ibi)2006-06-27
IBI THERAPY DUAL 8 ABLATION CATHETERS (P040042/S001)Irvine Biomedical,Inc.(Ibi)2005-12-21
THERAPY DUAL 8 CARDIAC ABLATION SYSTEM,THERAM 8MM THERMISTER ABLATION CATHETER SAFIRE TX ABLATION CATHETER (P040042)Irvine Biomedical,Inc.(Ibi)2005-11-18

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