510(k) K063076 ยท OWQ Reprocessed Intravascular Ultrasound Catheter
REPROCESSED DIAGNOSTIC ULTRASOUND CATHETER
| Applicant | Ascent Healthcare Solutions, Phoenix AZ, US |
| Decision | Substantially Equivalent, Mar 29, 2007 |
| Received | Oct 6, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K063076
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.