510(k) K081341 ยท DYB Introducer, Catheter
REINFORCED CATHETER INTRODUCER SYSTEM (RCIS)
| Applicant | Thomas Medical Products, Inc., Malvern PA, US |
| Decision | Substantially Equivalent, May 14, 2008 |
| Received | May 13, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K081341
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.