510(k) K925099 ยท DTB Permanent Pacemaker Electrode
POSSIS MEDICAL MYOPORE BIPOLAR SUTURELESS MYCARDIA
| Applicant | Possis Medical, Inc., Minneapolis MN, US |
| Decision | Substantially Equivalent, Jun 22, 1993 |
| Received | Oct 8, 1992 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K925099
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 29, 2009 | Greatbatch Medical Enpath Myopore Sutureless Myocardial Pacing Lead, Ref: 511211. the contents of the inner package have been sterilized by ethylene-oxide gas. Manufactured by: Enpath Medical, Inc., 2300 Berkshire L Terminated |
DTB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.