510(k) K853446 ยท DTB Permanent Pacemaker Electrode
POLYSAFE CCS TRIFIX ENDOCARDIAL PACING LEAD SV-107
| Applicant | Cardiac Control Systems, Inc., Palm Coast FL, US |
| Decision | Substantially Equivalent, Jan 13, 1986 |
| Received | Aug 16, 1985 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K853446
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.