510(k) K223026 ยท OWQ Reprocessed Intravascular Ultrasound Catheter
NES Reprocessed Eagle Eye Platinum RX Digital IVUS Catheter
| Applicant | Northeast Scientific, Inc., Waterbury CT, US |
| Decision | Substantially Equivalent, Feb 3, 2023 |
| Received | Sep 29, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K223026
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.