510(k) K914489 ยท DTB Permanent Pacemaker Electrode
NEW EXTRUSION VENDOR FOR POLYURETHANE TUBING
| Applicant | Telectronics Pacing Systems, Inc., Englewood CO, US |
| Decision | Substantially Equivalent, Aug 17, 1992 |
| Received | Oct 8, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K914489
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.