510(k) K200195 ยท OBJ Catheter, Ultrasound, Intravascular
NES Reprocessed Visions PV .014P RX Digital IVUS Catheter
| Applicant | Northeast Scientific, Inc., Waterbury CT, US |
| Decision | Substantially Equivalent, Jun 22, 2020 |
| Received | Jan 27, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K200195
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.