510(k) K124046 ยท DYB Introducer, Catheter
VALVED TEARAWAY INTRODUCER GENERATION II
| Applicant | Medical Components, Inc., Harleysville PA, US |
| Decision | Substantially Equivalent, Jun 3, 2013 |
| Received | Dec 31, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K124046
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.