Irvine Biomedical. Inc.
Irvine, CA, US
IRVINE BIOMEDICAL. INC. appears in FDA device records in Irvine, CA. FDA records list 12 510(k) clearances between and , 106 PMA records and one registered establishment. As of , FDA records show 2 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
1 nameFDA records resolved to Irvine Biomedical. Inc. carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Irvine Biomedical, Inc., A St. Jude Medical Company510(k), enforcement report, recall
510(k) clearance history
FDA records hold 12 510(k) clearances for Irvine Biomedical. Inc. between 1995 and 2014. The busiest year on record is 1999, with 3. The most recent is 2014, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1995 | 1 |
| 1997 | 1 |
| 1998 | 1 |
| 1999 | 3 |
| 2001 | 1 |
| 2004 | 1 |
| 2006 | 2 |
| 2008 | 1 |
| 2014 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K133853 | VIEWFLEX XTRA ICE CATHETER | OBJ | Substantially Equivalent | |
| K082061 | INQUIRY H-CURVE TV STEERABLE DIAGNOSTIC CATHETER | DRF | Substantially Equivalent | |
| K060757 | INQUIRY OPTIMA PLUS STEERABLE ELECTROPHYSIOLOGY CATHETER | DRF | Substantially Equivalent | |
| K053582 | INQUIRY AFOCUS II DIAGNOSTIC CATHETER | DRF | Substantially Equivalent | |
| K042775 | INQUIRY AFOCUS, INQUIRY AFOCUS II AND INQUIRY OPTIMA STEERABLE ELECTROPHYSIOLOGY CATHETER | DRF | Substantially Equivalent | |
| K010471 | AFOCUS ELECTROPYSIOLOGY CATHETER SYSTEM, MODELS 81550, 81567, 81568, 81569 | DRF | Substantially Equivalent | |
| K991878 | LUMA-CATH STEERABLE EP CATHETERS | DRF | Substantially Equivalent | |
| K991025 | LUMA-CATH FIXED CURVE EP CATHETERS | DRF | Substantially Equivalent | |
| K990958 | ORTHOGONAL EP CATHETERS | DRF | Substantially Equivalent | |
| K982232 | MODIFICATION OF THE IBI-1100 STEERABLE ELECTROPHYSIOLOGY CATHETER SYSTEM | DRF | Substantially Equivalent | |
| K961924 | IBI-1100 STEERABLE ELECTROPHYSIOLOGY CATHETER SYSTEM | DRF | Substantially Equivalent | |
| K946333 | IBI-1000(TM) ELECTROPHYSIOLOGY CATHTER | DRF | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 2030404 | 1000519796 | IRVINE BIOMEDICAL. INC. | 2375 Morse Ave, IRVINE, CA 92614 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- IKDCable, Electrode
- LPBCardiac Ablation Percutaneous Catheter
- DRFCatheter, Electrode Recording, Or Probe, Electrode Recording
- MTDCatheter, Intracardiac Mapping, High-Density Array
- OADCatheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter
- OBJCatheter, Ultrasound, Intravascular
- DQKComputer, Diagnostic, Programmable
- DYBIntroducer, Catheter
- OWQReprocessed Intravascular Ultrasound Catheter
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-3012-2020 | Inquiry Steerable Diagnostic Catheter, REF: IBI-87002 - Product Usage: INDICATIONS FOR USE The Inquiry fixed curve and steerable electrophysiology catheters are used for electrogram recording and cardiac stimulation during diagnostic electrophysiology studies. The catheters are commonly placed at the high right atrium, right ventricular apex, and HIS bundle. | Steerable diagnostic catheter packages labeled Model IBI-81104, batch 7397352 incorrectly contained Model IBI-87002, batch 7397307. Packages labeled Model IBI-87002, batch 7397307 incorrectly contained Model IBI-81104, batch 7397352.If physicians fail to observe the catheter difference, the intracardiac electrograms will not be representative of the desired signals, could result in procedure delay | Class II | Terminated | |
| Z-3011-2020 | Inquiry Steerable Diagnostic Catheter, REF: IBI-81104 - Product Usage: INDICATIONS FOR USE The Inquiry fixed curve and steerable electrophysiology catheters are used for electrogram recording and cardiac stimulation during diagnostic electrophysiology studies. The catheters are commonly placed at the high right atrium, right ventricular apex, and HIS bundle. | Steerable diagnostic catheter packages labeled Model IBI-81104, batch 7397352 incorrectly contained Model IBI-87002, batch 7397307. Packages labeled Model IBI-87002, batch 7397307 incorrectly contained Model IBI-81104, batch 7397352.If physicians fail to observe the catheter difference, the intracardiac electrograms will not be representative of the desired signals, could result in procedure delay | Class II | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain