510(k) K961924 ยท DRF Catheter, Electrode Recording, Or Probe, Electrode Recording
IBI-1100 STEERABLE ELECTROPHYSIOLOGY CATHETER SYSTEM
| Applicant | Irvine Biomedical, Inc., Irvine CA, US |
| Decision | Substantially Equivalent, Apr 11, 1997 |
| Received | May 17, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K961924
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 24, 2020 | Irvine Biomedical Inc, a St. Jude Medical Co. 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 card Terminated |
DRF | None listed |
| Aug 24, 2020 | Irvine Biomedical Inc, a St. Jude Medical Co. 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 card Terminated |
DRF | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.