510(k) K861464 ยท DTB Permanent Pacemaker Electrode
LEAD BODY CHANGES TO HI PERFORM & FAST-PASS LEADS
| Applicant | Pacesetter Systems, Sylmar CA, US |
| Decision | Substantially Equivalent, May 19, 1986 |
| Received | Apr 21, 1986 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K861464
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.