510(k) K072248 ยท DYB Introducer, Catheter
VIAPEEL PEELABLE INTRODUCER
| Applicant | Enpath Medical, Inc., Plymouth MN, US |
| Decision | Substantially Equivalent, Nov 9, 2007 |
| Received | Aug 13, 2007 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K072248
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 11, 2016 | Greatbatch Medical ViaPeel PTFE Peelable Introducer 5FR, Part Number 10890-006 Terminated |
DYB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.