510(k) K210655 ยท OWQ Reprocessed Intravascular Ultrasound Catheter
Reprocessed Eagle Eye Platinum RX Digital IVUS Catheter
| Applicant | Innovative Health, LLC, Scottsdale AZ, US |
| Decision | Substantially Equivalent, May 25, 2022 |
| Received | Mar 4, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K210655
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.