510(k) K112407 ยท DYB Introducer, Catheter
SMITH MEDICAL PEEL-AWAY SHEATH INTRODUCERS
| Applicant | Smiths Medical MD, Inc., St. Paul MN, US |
| Decision | Substantially Equivalent, Feb 9, 2012 |
| Received | Aug 22, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K112407
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.