510(k) K973713 ยท ITX Transducer, Ultrasonic, Diagnostic
22 GAUGE P.D. ACCESS VASCULAR ACCESS DEVICE (CATHETER/NEEDLE ASSEMBLY), 24 GAUGE P.D. ACCESS VASCULAR ACCESS DEVICE (CAR
| Applicant | Cardiovascular Dynamics, Inc., Irvine CA, US |
| Decision | Substantially Equivalent, Jan 23, 1998 |
| Received | Sep 29, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K973713
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.