510(k) K181126 ยท OWQ Reprocessed Intravascular Ultrasound Catheter
Reprocessed Visions PV .035 Digital IVUS Catheter
| Applicant | Innovative Health, LLC, Scottsdale AZ, US |
| Decision | Substantially Equivalent, Jan 18, 2019 |
| Received | Apr 30, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K181126
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.