510(k) K042308 ยท DYB Introducer, Catheter
SHEATH-IN-SHEATH CATHETER, 18FR, MODEL S00018; SHEATH-IN-SHEATH CATHETER, 6 FR., MODEL S00019
| Applicant | Facile Medical, Inc., Mission Viejo CA, US |
| Decision | Substantially Equivalent, Feb 17, 2005 |
| Received | Aug 25, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K042308
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.