510(k) K002603 ยท LDF Electrode, Pacemaker, Temporary
ZYNERGY BALLOONPACE BALLOON GUIDED PACING AND MONITORING CATHETER
| Applicant | Zcv ,Inc., Edison NJ, US |
| Decision | Substantially Equivalent, Jan 8, 2001 |
| Received | Aug 22, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K002603
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.