FDA.reportPublic FDA data

IRVINE BIOMEDICAL. INC.

Matched from indexed company URL: Irvine Biomedical, Inc.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
20304041000519796IRVINE BIOMEDICAL. INC.1N2026-01-012375 Morse Ave IRVINE CA US 92614

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
05414734303415Inquiry™ - Steerable Diagnostic Catheter 1110-6-2-L1-TE2BE2+1(855)478-5833customerservice@sjm.com
05414734303538Inquiry™ - Steerable Diagnostic Catheter 1120-6-13-L1+1(855)478-5833customerservice@sjm.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
59391906099585P110016THERAPY COOL PATH DUO/ SAFIRE BLU DUO ABLATION CATHETER AND IBI 1500T9-CP V1.6 CARDIAC ABLATION GENERATOROAD2012-01-25
59391235664855P060019IBI THERAPY COOL PATH ABLATION CATHETER & IBI-1500T9 RFOAD2007-03-16
59391538198683P040042THERAPY DUAL 8 CARDIAC ABLATION SYSTEM,THERAM 8MM THERMISTER ABLATION CATHETER SAFIRE TX ABLATION CATHETEROAD2005-11-18
59391015723031P040014IBI THERAPY CARDIAC ABLATION SYSTEM ERS/ 1500T RF GENERATORLPB2005-01-14
59391238912569K991878LUMA-CATH STEERABLE EP CATHETERSDRF1999-12-10
59391716995144K982232MODIFICATION OF THE IBI-1100 STEERABLE ELECTROPHYSIOLOGY CATHETER SYSTEMDRF1998-07-25
59391519050996K961924IBI-1100 STEERABLE ELECTROPHYSIOLOGY CATHETER SYSTEMDRF1997-04-11
59391368438843K946333IBI-1000(TM) ELECTROPHYSIOLOGY CATHTERDRF1995-07-18
59391826487014K251231ViewFlex™ X ICE Catheter, Sensor Enabled™OBJ2025-05-20
59391219462594K251211ViewFlex™ Xtra ICE Catheter; ViewFlex™ Eco Reprocessed ICE Catheter; Advisor™ HD Grid Mapping Catheter, Sensor Enabled™; Advisor™ HD Grid X Mapping Catheter, Sensor Enabled™; Agilis™ NxT Steerable Introducer; Agilis™ NxT Steerable Introducer Dual-Reach™OBJ2025-05-23
59391921629173K242016EnSite™ X EP SystemDQK2024-08-09
59391296019727K223077ViewFlex Xtra ICE CatheterOBJ2022-12-07
59391351487501K133853VIEWFLEX XTRA ICE CATHETEROBJ2014-05-19
59391467212785K101623INQUIRY AFOCUSII DIAGNOSTIC CATHETERDRF2010-08-13
59391633340015K060757INQUIRY OPTIMA PLUS STEERABLE ELECTROPHYSIOLOGY CATHETERDRF2006-04-19
59391614043964K042775INQUIRY AFOCUS, INQUIRY AFOCUS II AND INQUIRY OPTIMA STEERABLE ELECTROPHYSIOLOGY CATHETERDRF2004-11-04
59391119662764K010471AFOCUS ELECTROPYSIOLOGY CATHETER SYSTEM, MODELS 81550, 81567, 81568, 81569DRF2001-06-06
59391038117842
59391244226634
59391333695468
59391734136513
59391944635198

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
DRF82010-08-13
OBJ42025-05-23
OAD32012-01-25
DQK12024-08-09
LPB12005-01-14

PMA#

Safire Ablation Catheter

2022-12-08

IRVINE BIOMEDICAL,INC.(IBI)2375 Morse Ave.irvine, CA 92614 PMA NumberP040042 Supplement NumberS054 Date Received11/14/2022 Decision Date12/08/2022 Product Code OAD  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Cha...

144 records. Showing 1-40. Next

PMN#

GUDID#

200 records. Showing 1-40. Next