510(k) K864564 ยท DTB Permanent Pacemaker Electrode
MODEL 486-05 POLYFLEX(R) IMPLANTABLE PACING LEAD
| Applicant | Intermedics, Inc., Freeport TX, US |
| Decision | Substantially Equivalent, Dec 5, 1986 |
| Received | Nov 19, 1986 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K864564
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.