510(k) K081394 ยท DYB Introducer, Catheter
PTFE INTERLOCK PEELABLE INTRODUCERS
| Applicant | Enpath Medical, Inc., Plymouth MN, US |
| Decision | Substantially Equivalent, Sep 15, 2008 |
| Received | May 19, 2008 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K081394
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.