510(k) K963738 ยท DTB Permanent Pacemaker Electrode
STELA MODEL BJ44 AND BJ45 PACING LEADS
| Applicant | Ela Medical, Inc., Minnetonka MN, US |
| Decision | Substantially Equivalent - Subject to Tracking & PMS, May 23, 1997 |
| Received | Sep 17, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K963738
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.