510(k) K972574 ยท DTB Permanent Pacemaker Electrode
STELA MODEL UJ45 PACING LEADS
| Applicant | Ela Medical, Inc., Plymouth MN, US |
| Decision | Substantially Equivalent - Subject to Tracking Reg., Jan 8, 1998 |
| Received | Jul 10, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K972574
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.