510(k) K202042 ยท OWQ Reprocessed Intravascular Ultrasound Catheter
Reprocessed ViewFlex Xtra Ice Diagnostic Ultrasound Catheter
| Applicant | Innovative Health, LLC, Scottsdale AZ, US |
| Decision | Substantially Equivalent, Nov 20, 2020 |
| Received | Jul 23, 2020 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K202042
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.