510(k) K991878 ยท DRF Catheter, Electrode Recording, Or Probe, Electrode Recording
LUMA-CATH STEERABLE EP CATHETERS
| Applicant | Irvine Biomedical, Inc., Irvine CA, US |
| Decision | Substantially Equivalent, Dec 10, 1999 |
| Received | Jun 2, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K991878
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.