510(k) K012489 ยท DYB Introducer, Catheter
MODIFICATION TO: X-SEPT TRANSSEPTAL SHEALTH AND TRANSITION CATHETER (WITH DILATOR), MODELS PL-12-12-09, PL-12-12-10
| Applicant | Appriva Medical, Inc., Sunnyvale CA, US |
| Decision | Substantially Equivalent, Aug 30, 2001 |
| Received | Aug 3, 2001 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K012489
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.