510(k) K250592 ยท OWQ Reprocessed Intravascular Ultrasound Catheter
NES Reprocessed Visions PV .018 Digital IVUS Catheter (R-86700)
| Applicant | Northeast Scientific, Inc., Waterbury CT, US |
| Decision | Substantially Equivalent, May 12, 2025 |
| Received | Feb 27, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K250592
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.