510(k) K002054 ยท DYB Introducer, Catheter
X-SEPT TRANSSEPTAL SHEATH AND TRANSITION CATHETER, MODEL MV-03-09-90, MV-03-10-90, MV-03-11-90, MV-03-09-120, MV-03-10-1
| Applicant | Appriva Medical, Inc., Sunnyvale CA, US |
| Decision | Substantially Equivalent, Feb 16, 2001 |
| Received | Jul 6, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K002054
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.