510(k) K163560 ยท OWQ Reprocessed Intravascular Ultrasound Catheter
Reprocessed AcuNav Diagnostic Ultrasound Catheter
| Applicant | Innovative Health, LLC, Scottsdale AZ, US |
| Decision | Substantially Equivalent, Jul 12, 2017 |
| Received | Dec 19, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K163560
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.