510(k) K093232 ยท DYB Introducer, Catheter
OPTISEAL ENPATH VALVED PTFE PEELABLE INTRODUCER
| Applicant | Great Batch Medical, Plymouth MN, US |
| Decision | Substantially Equivalent, Mar 15, 2010 |
| Received | Oct 14, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K093232
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 27, 2010 | Greatbatch Medical Greatbatch OptiSeal Valved PTFE Peelable Introducer, Model 1000093-001, 1000093-002, 1000093-003, 1000093-004, 1000093-005, 1000093-006, 1000093-007. Sterilized using Ethylene Oxide. Greatbatch Med Terminated |
DYB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.