Company ยท US
Irvine Biomedical, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1995 to 2008. Name variants (Inc, Corp, punctuation) are merged.
11510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| DRF | Catheter, Electrode Recording, Or Probe, Electrode Recording | 11 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 19, 2008 | K082061 | INQUIRY H-CURVE TV STEERABLE DIAGNOSTIC CATHETER Irvine Biomedical, Inc. | DRF |
| Apr 19, 2006 | K060757 | INQUIRY OPTIMA PLUS STEERABLE ELECTROPHYSIOLOGY CATHETER Irvine Biomedical, Inc. | DRF |
| Mar 21, 2006 | K053582 | INQUIRY AFOCUS II DIAGNOSTIC CATHETER Irvine Biomedical, Inc. | DRF |
| Nov 4, 2004 | K042775 | INQUIRY AFOCUS, INQUIRY AFOCUS II AND INQUIRY OPTIMA STEERABLE ELECTROPHYSIOLOGY CATHETER Irvine Biomedical, Inc. | DRF |
| Jun 6, 2001 | K010471 | AFOCUS ELECTROPYSIOLOGY CATHETER SYSTEM, MODELS 81550, 81567, 81568, 81569 Irvine Biomedical, Inc. | DRF |
| Dec 10, 1999 | K991878 | LUMA-CATH STEERABLE EP CATHETERS Irvine Biomedical, Inc. | DRF |
| Oct 15, 1999 | K991025 | LUMA-CATH FIXED CURVE EP CATHETERS Irvine Biomedical, Inc. | DRF |
| Jun 3, 1999 | K990958 | ORTHOGONAL EP CATHETERS Irvine Biomedical, Inc. | DRF |
| Jul 25, 1998 | K982232 | MODIFICATION OF THE IBI-1100 STEERABLE ELECTROPHYSIOLOGY CATHETER SYSTEM Irvine Biomedical, Inc. | DRF |
| Apr 11, 1997 | K961924 | IBI-1100 STEERABLE ELECTROPHYSIOLOGY CATHETER SYSTEM Irvine Biomedical, Inc. | DRF |
| Jul 18, 1995 | K946333 | IBI-1000(TM) ELECTROPHYSIOLOGY CATHTER Irvine Biomedical, Inc. | DRF |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||