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Irvine Biomedical, Inc.

106 FDA 510(k) clearances · PMA applicant

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RecordFirmDate
Cool Point™ Tubing Set (P060019/S058)Irvine Biomedical, Inc.2025-12-19
IBI THERAPY COOL PATH ABLATION CATHETER & IBI-1500T9 RF (P060019/S057)Irvine Biomedical, Inc.2025-05-28
Therapy Ablation Catheter (4mm Tip Thermistor and Bi-Directional); Cables (P040014/S050)Irvine Biomedical, Inc.2025-04-10
Therapy™ Ablation Catheter (4mm and 8mm), Cables 16- 17- 18- & 19- (P040014/S049)Irvine Biomedical, Inc.2024-10-15
Cool Point™ Tubing Set (P060019/S056)Irvine Biomedical, Inc.2024-05-22
Ampere™ Generator, Ampere™ Remote Control, Ampere™ Generator System Kit (P040014/S048)Irvine Biomedical, Inc.2023-11-29
Ampere™ Generator, Ampere™ Remote Control, Ampere™ Generator System Kit (P060019/S055)Irvine Biomedical, Inc.2023-11-29
Therapy Ablation Catheter (4mm and 8mm), Electrophysiology Cables (16, 17, 18 and 19 Series) (P040014/S047)Irvine Biomedical, Inc.2022-12-16
Therapy Ablation Catheter (4mm and 8mm), Electrophysiology Cables (16, 17, 18 and 19 Series) (P040014/S046)Irvine Biomedical, Inc.2022-11-15
Ampere™ Generator (P040014/S045)Irvine Biomedical, Inc.2021-10-14
Ampere™ Generator (P060019/S054)Irvine Biomedical, Inc.2021-10-14
Therapy Cool Path (P060019/S053)Irvine Biomedical, Inc.2021-05-18
Therapy Cool Path Ablation Catheter (P060019/S052)Irvine Biomedical, Inc.2021-05-04
Therapy Ablation Catheter, Therapy 4MM Thermistor Ablation Catheter, Therapy Bi-Directional Ablation Catheter (P040014/S044)Irvine Biomedical, Inc.2021-05-04
Therapy Cool Path (P060019/S051)Irvine Biomedical, Inc.2021-03-24
Therapy and Therapy Dual-8 (P040014/S043)Irvine Biomedical, Inc.2021-03-24
Therapy Cool Path, Safire BLU, Safire BLU SP, and Therapy Cool Path SP Ablation Catheters (P060019/S050)Irvine Biomedical, Inc.2021-03-12
Therapy Ablation Catheters (P040014/S042)Irvine Biomedical, Inc.2021-03-12
Therapy Ablation Catheters (P040014/S040)Irvine Biomedical, Inc.2020-11-02
Therapy Cool Path, Safire BLU, Safire BLU SP, and Therapy Cool Path SP Ablation Catheters (P060019/S048)Irvine Biomedical, Inc.2020-11-02
Therapy Cool Path SP Ablation Catheter (P060019/S049)Irvine Biomedical, Inc.2020-10-16
Therapy Ablation Catheter (P040014/S041)Irvine Biomedical, Inc.2020-10-16
Therapy Cool Path Ablation Catheter (including all braid catheter) (P060019/S047)Irvine Biomedical, Inc.2020-04-24
Therapy Ablation Catheter (including Bi-Directional Catheter) Therapy 4mm Thermistor Ablation Catheter (P040014/S039)Irvine Biomedical, Inc.2020-04-24
Therapy Cool Path Ablation Catheter (P060019/S046)Irvine Biomedical, Inc.2020-03-04
Therapy Ablation Catheter, Therapy 4mm Thermistor Ablation Catheter and Therapy Bi-Directional Ablation Catheter (P040014/S038)Irvine Biomedical, Inc.2020-03-04
Therapy Ablation , Therapy 4mm Thermistor Ablation Catheter (P040014/S037)Irvine Biomedical, Inc.2019-08-28
Cool Point Irrigation Pump (P060019/S043)Irvine Biomedical, Inc.2019-08-16
Electrophysiology Cable, Therapy Ablation Catheter (P040014/S036)Irvine Biomedical, Inc.2019-04-11
Therapy Cool Path Ablation Catheter (P060019/S045)Irvine Biomedical, Inc.2019-04-11
Therapy Ablation Catheters (P040014/S035)Irvine Biomedical, Inc.2019-01-10
Therapy Cool Path, Safire BLU, Safire BLU SP, Therapy Cool Path SP, 1500T9-CP RF Generators (P060019/S044)Irvine Biomedical, Inc.2019-01-10
Therapy Cool Path, Safire BLU, Safire BLU SP, Therapy Cool Path SP, 1500T9-CP Generators (P060019/S042)Irvine Biomedical, Inc.2018-03-06
Therapy Ablation Catheters (P040014/S034)Irvine Biomedical, Inc.2018-03-06
Cool Point Tubing Set (P060019/S041)Irvine Biomedical, Inc.2017-11-02
Therapy Cool Path Ablation Catheters, Therapy Cool Path SP Ablation Catheter and Safire BLU SP Ablation Catheter (P060019/S039)Irvine Biomedical, Inc.2017-05-19
Therapy Ablation Catheter including Bi-Directional catheter and Therapy 4mm Thermistor Ablation Catheter (P040014/S032)Irvine Biomedical, Inc.2017-05-19
Therapy Cool Path Ablation Catheters (P060019/S038)Irvine Biomedical, Inc.2016-09-08
Therapy Ablation Catheters (P040014/S031)Irvine Biomedical, Inc.2016-09-08
THERAPY ABLATION CATHETER (INCLUDING BI-DIRECTIONAL) THERAPY 4MM THERMISTOR ABLATION CATHETER (P040014/S030)Irvine Biomedical, Inc.2016-06-24
THERAPY COOL PATH ABLATION CATHETER, THERAPY COOL PATH SP ABLATION CATHETER, SAFIRE BLU ABLATION CATHETER (P060019/S037)Irvine Biomedical, Inc.2016-06-24
THERAPY COOL PATH ABLATION CATHETER, THERAPY COOL PATH SP ABLATION CATHETE, SAFIRE BLU ABLATION CATHETER, SAFIRE BLU SP (P060019/S033)Irvine Biomedical, Inc.2016-04-29
THERAPY CARDIAC ABLATION CATHETER (P040014/S026)Irvine Biomedical, Inc.2016-04-29
IBI THERAPY COOL PATH ABLATION CATHETER & IBI-1500T9 RF (P060019/S036)Irvine Biomedical, Inc.2016-02-29
IBI THERAPY CARDIAC ABLATION SYSTEM ERS/ 1500T RF GENERATOR (P040014/S029)Irvine Biomedical, Inc.2016-02-29
THERAPY COOL PATH ABLATION CATHETER AND IBI-1500T9 RF ABLATION GENERATOR (P060019/S032)Irvine Biomedical, Inc.2016-02-24
THERAPY ABLATION CATHETERS (P040014/S028)Irvine Biomedical, Inc.2016-02-18
THERAPY COOL PATH, SAFIRE BLU, SAFIRE BLU SP AND THERAPY COOL PATH SP ABLATION CATHETERS, AND 1500T9-CP RF GENERATORS (P060019/S035)Irvine Biomedical, Inc.2016-02-18
THERAPY COOL PATH, SAFIRE BLU, SAFIRE BLU SP, AND THERAPY COOL PATH SP ABLATION CATHETERS (P060019/S034)Irvine Biomedical, Inc.2015-10-21
THERAPY ABLATION CATHETERS (P040014/S027)Irvine Biomedical, Inc.2015-10-21
THERAPY COOL PATH ABLATION CATHETER (P060019/S030)Irvine Biomedical, Inc.2015-07-09
THERAPY ABLATION CATHETER (P040014/S024)Irvine Biomedical, Inc.2015-07-09
THERAPY ABLATION CATHETER INCLUDING BI-DIRECTIONAL CATHETER AND THERAPY 4MM THERNISTOR ABLATION CATHETER (P040014/S025)Irvine Biomedical, Inc.2015-05-20
THERAPY COOL PATH ABLATION CATHETERS (INCLUDING ALL BRAID MODELS) (P060019/S031)Irvine Biomedical, Inc.2015-05-20
THERAPY CATHETER (P040014/S023)Irvine Biomedical, Inc.2015-04-09
THERAPY COOL PATH CATHETER (P060019/S028)Irvine Biomedical, Inc.2015-04-09
THE COOL POINT IRRIGATION PUMP (P060019/S029)Irvine Biomedical, Inc.2014-11-06
COOL POINT(TM) TUBING SET (P060019/S025)Irvine Biomedical, Inc.2014-05-19
THERAPY CATHETER (NON-IRRIGATED) (P040014/S022)Irvine Biomedical, Inc.2014-04-28
THERAPY COOL PATH CATHETER(6 HOLE IRRIGATED) AND BI-DIRECTIONAL, SAFIRE BLU (6HOLE IRRIGATED) SAFIRE BLUE SP AND THERAPY (P060019/S027)Irvine Biomedical, Inc.2014-04-28
THERAPY COOL PATH CATHETER (6 HOLE IRRIGATED) AND BI-DIRECTIONAL, SAFIRE BLU (6 HOLE IRRIGATED), SAFIRE BLU SP (P060019/S026)Irvine Biomedical, Inc.2014-03-21
THERAPY CATHETER (NON-IRRIGATED) (P040014/S021)Irvine Biomedical, Inc.2014-03-21
THERAPY ABLATION CATHETERS (P040014/S020)Irvine Biomedical, Inc.2013-09-27
THERAPY COOL PATH ABLATION CATHETERS (P060019/S024)Irvine Biomedical, Inc.2013-09-27
SAFIRE BLU AND THERAPY COOL BI-DIRECTIONAL ABLATION CATHETERS (P060019/S023)Irvine Biomedical, Inc.2012-11-29
THERAPY COOL PATH ABLATION CATHETER (P060019/S022)Irvine Biomedical, Inc.2012-09-07
THERAPY CARDIAC ABLATION SYSTEM (P040014/S019)Irvine Biomedical, Inc.2012-08-22
THERAPY COOL PATH ABLATION CATHETER & IBI 1500T9 (P060019/S020)Irvine Biomedical, Inc.2012-08-22
SAFIRE BLU SP ABLATION CATHETER, THERAPY COOL PATH SP (BI-DIRECTIONAL) ABLATION CATHETER (P060019/S021)Irvine Biomedical, Inc.2012-07-10
THERAPY COOL PATH ABLATION CATHETER & IBI 1500T9 (P060019/S019)Irvine Biomedical, Inc.2011-11-10
THERAPY CARDIAC ABLATION SYSTEM (P040014/S018)Irvine Biomedical, Inc.2011-11-10
THERAPY CARDIAC ABLATION CATHETER (P040014/S017)Irvine Biomedical, Inc.2011-06-06
SAFIRE BLU IRRIGATED ABLATION CATHETER & THERAPY COOL PATH CATHETER (P060019/S009)Irvine Biomedical, Inc.2011-02-23
THERAPY COOL PATH ABLATION CATHETER (P060019/S017)Irvine Biomedical, Inc.2011-02-17
THERAPY/THERAPY BI-DIRECTIONAL/THERAPY 4MM THERMISTOR ABLATION CATHETERS (P040014/S016)Irvine Biomedical, Inc.2011-02-17
THERAPY ABLATION CATHETER (P040014/S015)Irvine Biomedical, Inc.2011-01-11
THERAPY COOL PATH ABLATION CATHETER (P060019/S015)Irvine Biomedical, Inc.2011-01-11
SAFIRE BLU AND THERAPY COOL PATH BI-DIRECTIONAL ABLATION CATHETERS (P060019/S016)Irvine Biomedical, Inc.2010-12-23
THERAPY COOL PATH ABLATION CATHETER (P060019/S013)Irvine Biomedical, Inc.2010-12-03
COOL POINT TUBING SET (P060019/S014)Irvine Biomedical, Inc.2010-10-29
THERAPY COOL PATH ABLATION CATHETER (P060019/S011)Irvine Biomedical, Inc.2010-03-23
THERAPY CARDIAC ABLATION CATHETER/THERAPY 4MM THERMISTOR/THERAPY BI-DIRECTIONAL CATHETERS (P040014/S013)Irvine Biomedical, Inc.2010-03-23
THERAPY CARDIAC ABLATION CATHETER (P040014/S012)Irvine Biomedical, Inc.2010-01-12
THERAPY COOL PATH ABLATION CATHETER (P060019/S010)Irvine Biomedical, Inc.2010-01-12
THERAPY CARDIAC ABLATION CATHETER (P040014/S011)Irvine Biomedical, Inc.2009-08-28
THERAPY CARDIAC ABLATION CATHETERS (P040014/S008)Irvine Biomedical, Inc.2009-06-17
THERAPY COOL PATH ABLATION CATHETER & IBI-1500T9 RF ABLATION GENERATOR (P060019/S005)Irvine Biomedical, Inc.2009-06-12
THERAPY ABLATION CATHETERS (P040014/S010)Irvine Biomedical, Inc.2009-06-01
THERAPY COOL PATH ABLATION CATHETERS (P060019/S008)Irvine Biomedical, Inc.2009-06-01
THERAPY CARDIAC ABLATION CATHETER (P040014/S009)Irvine Biomedical, Inc.2008-12-10
THERAPY COOL PATH ABLATION CATHETERS (P060019/S007)Irvine Biomedical, Inc.2008-12-10
THERAPY COOL PATH ABLATION CATHETER AND IBI-1500T9 RF ABLATION GENERATOR (P060019/S004)Irvine Biomedical, Inc.2008-06-13
THERAPY CARDIAC ABLATION CATHETERS (P040014/S007)Irvine Biomedical, Inc.2008-06-09
THERAPY COOL PATH CARDIAC ABLATION CATHETER AND 1500T9 CARDIAC ABLATION GENERATOR (P060019/S003)Irvine Biomedical, Inc.2007-07-26
THERAPY COOL PATH CARDIAC ABLATION CATHETER AND 1500T9 CARDIAC ABLATION GENERATOR (P060019/S002)Irvine Biomedical, Inc.2007-07-17
THERAPY COOL PATH CARDIAC ABLATION CATHETER AND 1500T9 CARDIAC ABLATION GENERATOR (P060019/S001)Irvine Biomedical, Inc.2007-07-13
IBI THERAPY CARDIAC ABLATION SYSTEM ERS/1500T RF GENERATOR (P040014/S005)Irvine Biomedical, Inc.2007-07-13
IBI THERAPY CARDIAC ABLATION SYSTEM (P040014/S006)Irvine Biomedical, Inc.2007-03-16
IBI THERAPY COOL PATH ABLATION CATHETER & IBI-1500T9 RF (P060019)Irvine Biomedical, Inc.2007-03-16
THERAPY ABLATION CATHETERS (P040014/S004)Irvine Biomedical, Inc.2007-01-10
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