510(k) K963989 ยท ITX Transducer, Ultrasonic, Diagnostic
P.D. ACCESS (PERCUTANEOUS DOPPLER) VASCULAR ACCESS DEVICE
| Applicant | Cardiovascular Dynamics, Inc., Irvine CA, US |
| Decision | Substantially Equivalent, Apr 24, 1997 |
| Received | Oct 4, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K963989
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.