510(k) K853410 ยท DTR Heat-Exchanger, Cardiopulmonary Bypass
MODEL 492-03 POLYFLEX IMPLANTABLE PACING LEAD
| Applicant | Intermedics, Inc., Freeport TX, US |
| Decision | Substantially Equivalent, Oct 11, 1985 |
| Received | Aug 13, 1985 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K853410
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.