510(k) K230584 ยท OWQ Reprocessed Intravascular Ultrasound Catheter
Vein360 Reprocessed Visions PV.035 Digital IVUS Catheter
| Applicant | Vein 360, LLC, Blue Ash OH, US |
| Decision | Substantially Equivalent, Jun 6, 2023 |
| Received | Mar 2, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K230584
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.