IRVINE BIOMEDICAL, INC

FDA Filings

This page includes the latest FDA filings for IRVINE BIOMEDICAL, INC. Currently, you will find the latest 25 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

Latest Premarket Notifications

ManufacturerDevice NameDate
IRVINE BIOMEDICAL, INC. A ST.JUDE MEDICAL COMPANY
VIEWFLEX XTRA ICE CATHETER2014-05-19
IRVINE BIOMEDICAL,INC.(IBI)
IBI INQUIRY CLEARICE INTRACARDIAC ECHOCARDIOGRAPHY ULTRASOUND IMAGING CATHETER2007-03-20
IRVINE BIOMEDICAL, INC.
INQUIRY OPTIMA PLUS STEERABLE ELECTROPHYSIOLOGY CATHETER2006-04-19
IRVINE BIOMEDICAL, INC.
INQUIRY AFOCUS II DIAGNOSTIC CATHETER2006-03-21
IRVINE BIOMEDICAL, INC.
AFOCUS ELECTROPYSIOLOGY CATHETER SYSTEM, MODELS 81550, 81567, 81568, 815692001-06-06
IRVINE BIOMEDICAL, INC.
Luma-cath Steerable Ep Catheters1999-12-10
IRVINE BIOMEDICAL, INC.
LUMA-CATH FIXED CURVE EP CATHETERS1999-10-15
IRVINE BIOMEDICAL, INC.
Orthogonal Ep Catheters1999-06-03
IRVINE BIOMEDICAL, INC.
MODIFICATION OF THE IBI-1100 STEERABLE ELECTROPHYSIOLOGY CATHETER SYSTEM1998-07-25
IRVINE BIOMEDICAL, INC.
IBI-1100 STEERABLE ELECTROPHYSIOLOGY CATHETER SYSTEM1997-04-11
IRVINE BIOMEDICAL, INC.
IBI-1000(TM) ELECTROPHYSIOLOGY CATHTER1995-07-18

Latest Premarket Applications

PMAManufacturerDevice NameDate
IRVINE BIOMEDICAL, INC.
Therapy Cool Path Ablation Catheter2020-03-04
IRVINE BIOMEDICAL, INC.
Therapy Ablation Catheter, Therapy 4mm Thermistor Ablation Catheter and Therapy Bi-Directional Ablation Catheter2020-03-04
IRVINE BIOMEDICAL,INC.(IBI)
Therapy Dual 8 Ablation Catheter and Therapy 8mm Thermistor Ablation Catheter2020-03-04
IRVINE BIOMEDICAL, INC.
Therapy Ablation , Therapy 4mm Thermistor Ablation Catheter2019-08-28
IRVINE BIOMEDICAL,INC.(IBI)
Therapy Dual-8, Therapy 8mm Thermistor, Safire TX Ablation Catheter2019-08-28
IRVINE BIOMEDICAL, INC.
Therapy Cool Path Ablation Catheter2019-04-11
IRVINE BIOMEDICAL,INC.(IBI)
Electrophysiology Cable; SE-Safire TX, Catheter Extension Cable; Therapy 8mm, Thermistor, Dual 8, Safire TX Ablation Cat2019-04-11
IRVINE BIOMEDICAL, INC.
Electrophysiology Cable, Therapy Ablation Catheter2019-04-11
IRVINE BIOMEDICAL,INC.(IBI)
Therapy Dual 8, Therapy 8mm Thermistor, Safire TX Ablation Catheters, 1500T6 RF Generators, 1500T9 RF Generators2019-01-10
IRVINE BIOMEDICAL, INC.
Therapy Cool Path, Safire BLU, Safire BLU SP, Therapy Cool Path SP, 1500T9-CP RF Generators2019-01-10
IRVINE BIOMEDICAL, INC.
Therapy Ablation Catheters2019-01-10
IRVINE BIOMEDICAL, INC.
Therapy Ablation Catheters2018-03-06
IRVINE BIOMEDICAL, INC.
Therapy Cool Path, Safire BLU, Safire BLU SP, Therapy Cool Path SP, 1500T9-CP Generators2018-03-06
IRVINE BIOMEDICAL,INC.(IBI)
Therapy Dual 8, Therapy 8mm Thermistor, Safire TX Ablation Catheters, 1500T6 RF Generators, 1500T9 RF Generators2018-03-06
IRVINE BIOMEDICAL, INC.
Cool Point Tubing Set2017-11-02
IRVINE BIOMEDICAL, INC.
Therapy Cool Path Ablation Catheters, Therapy Cool Path SP Ablation Catheter and Safire BLU SP Ablation Catheter2017-05-19
IRVINE BIOMEDICAL,INC.(IBI)
Therapy Dual-8 Ablation Catheter, Therapy 8mm Thermistor Ablation Catheter, Safire TX Ablation Catheter2017-05-19
IRVINE BIOMEDICAL, INC.
Therapy Ablation Catheter including Bi-Directional catheter and Therapy 4mm Thermistor Ablation Catheter2017-05-19
IRVINE BIOMEDICAL, INC.
Therapy Cool Path Ablation Catheters2016-09-08
IRVINE BIOMEDICAL, INC.
Therapy Ablation Catheters2016-09-08
IRVINE BIOMEDICAL,INC.(IBI)
Therapy Dual 8 Ablation Catheters2016-09-08
IRVINE BIOMEDICAL,INC.(IBI)
THERAPY DUAL 8 THERAPY 8MM THERMISTER ABLATION CATHETER, SAFIRE TX BI-DIRECTIONAL ABLATION CATHETER2016-06-24
IRVINE BIOMEDICAL, INC.
THERAPY ABLATION CATHETER (INCLUDING BI-DIRECTIONAL) THERAPY 4MM THERMISTOR ABLATION CATHETER2016-06-24
IRVINE BIOMEDICAL, INC.
THERAPY COOL PATH ABLATION CATHETER, THERAPY COOL PATH SP ABLATION CATHETER, SAFIRE BLU ABLATION CATHETER2016-06-24
IRVINE BIOMEDICAL, INC.
THERAPY CARDIAC ABLATION CATHETER2016-04-29
IRVINE BIOMEDICAL, INC.
THERAPY COOL PATH ABLATION CATHETER, THERAPY COOL PATH SP ABLATION CATHETE, SAFIRE BLU ABLATION CATHETER, SAFIRE BLU SP2016-04-29
IRVINE BIOMEDICAL,INC.(IBI)
THERAPY DUAL 8 CATHETER,THERAPY 8MM THERMISTOR ABLATION CATHETER, SAFIRE TX, AND ASSOCIATED CABLES2016-04-29
IRVINE BIOMEDICAL, INC.
IBI THERAPY COOL PATH ABLATION CATHETER & IBI-1500T9 RF2016-02-29
IRVINE BIOMEDICAL,INC.(IBI)
THERAPY DUAL 8 CARDIAC ABLATION SYSTEM,THERAM 8MM THERMISTER ABLATION CATHETER SAFIRE TX ABLATION CATHETER2016-02-29
IRVINE BIOMEDICAL, INC.
IBI THERAPY CARDIAC ABLATION SYSTEM ERS/ 1500T RF GENERATOR2016-02-29

Latest De Novo Filings

De NovoManufacturerDevice NameDate

GUDID Registrations

Device GUDID
Device Name
ManufacturerDate
ViewFlex™
IRVINE BIOMEDICAL, INC.2019-07-22
Safire™ TX
IRVINE BIOMEDICAL, INC.2019-01-28
Safire™ TX
IRVINE BIOMEDICAL, INC.2019-01-28
Safire™ TX
IRVINE BIOMEDICAL, INC.2019-01-28
Safire™ TX
IRVINE BIOMEDICAL, INC.2019-01-28
Safire™ TX
IRVINE BIOMEDICAL, INC.2019-01-28
Safire™ TX
IRVINE BIOMEDICAL, INC.2019-01-28
Safire™ TX
IRVINE BIOMEDICAL, INC.2019-01-28
Safire™ TX
IRVINE BIOMEDICAL, INC.2019-01-28
Safire™ TX
IRVINE BIOMEDICAL, INC.2019-01-28
Cool Point™
IRVINE BIOMEDICAL, INC.2019-01-28
Therapy™
IRVINE BIOMEDICAL, INC.2019-01-28
Therapy™
IRVINE BIOMEDICAL, INC.2019-01-28
Therapy™
IRVINE BIOMEDICAL, INC.2019-01-28
Therapy™
IRVINE BIOMEDICAL, INC.2019-01-28
Therapy™
IRVINE BIOMEDICAL, INC.2019-01-28
Safire™ Blu™ Duo SP
IRVINE BIOMEDICAL, INC.2019-01-28
Safire™ Blu™ Duo SP
IRVINE BIOMEDICAL, INC.2019-01-28
Safire™ Blu™ Duo SP
IRVINE BIOMEDICAL, INC.2019-01-28
Safire™ Blu™ Duo SP
IRVINE BIOMEDICAL, INC.2019-01-28
Safire™ Blu™ SP
IRVINE BIOMEDICAL, INC.2019-01-28
Safire™ Blu™ SP
IRVINE BIOMEDICAL, INC.2019-01-28
Safire™ Blu™ SP
IRVINE BIOMEDICAL, INC.2019-01-28
Safire™ Blu™ SP
IRVINE BIOMEDICAL, INC.2019-01-28
Therapy™
IRVINE BIOMEDICAL, INC.2019-01-28
Therapy™
IRVINE BIOMEDICAL, INC.2019-01-28
Therapy™
IRVINE BIOMEDICAL, INC.2019-01-28
Therapy™
IRVINE BIOMEDICAL, INC.2019-01-28
SJM™
IRVINE BIOMEDICAL, INC.2019-01-28
SJM™
IRVINE BIOMEDICAL, INC.2019-01-28
SJM™
IRVINE BIOMEDICAL, INC.2019-01-28
SJM™
IRVINE BIOMEDICAL, INC.2019-01-28
SJM™
IRVINE BIOMEDICAL, INC.2019-01-28
SJM™
IRVINE BIOMEDICAL, INC.2019-01-28
SJM™
IRVINE BIOMEDICAL, INC.2019-01-28

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