510(k) K993448 ยท DTB Permanent Pacemaker Electrode
STELA UT46 AND BT45/46 STRAIGHT TINED PACING LEADS, STELA UJ45 AND BJ44/45 J-SHAPED TINED PACING LEADS
| Applicant | Ela Medical, Inc., Plymouth MN, US |
| Decision | Substantially Equivalent - Subject to Tracking Reg., Apr 10, 2000 |
| Received | Oct 12, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K993448
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.