510(k) K232584 ยท OWQ Reprocessed Intravascular Ultrasound Catheter
Vein360 Reprocessed Visions PV.014P Rx Digital IVUS Catheter, Vein360 Reprocessed Eagle Eye Platinum Rx Digital IVUS Catheter, Vein360 Reprocessed Eagle Eye Platinum ST Rx Digital IVUS Catheter
| Applicant | Vein 360, LLC, Blue Ash OH, US |
| Decision | Substantially Equivalent, Oct 24, 2023 |
| Received | Aug 25, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K232584
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.