510(k) K043084 ยท DYB Introducer, Catheter
PREMERE DELIVERY SHEATH, MODEL PDS
| Applicant | Velocimed, Inc., Maple Grove MN, US |
| Decision | Substantially Equivalent, May 2, 2005 |
| Received | Nov 8, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K043084
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.