510(k) K092425 ยท OWQ Reprocessed Intravascular Ultrasound Catheter
REPROCESSED 3D DIAGNOSTIC ULTRASOUND CATHETERS, MODEL SNDSTR10
| Applicant | Ascent Healthcare Solutions, Phoenix AZ, US |
| Decision | Substantially Equivalent, Oct 21, 2009 |
| Received | Aug 7, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K092425
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.