510(k) K190478 · OWQ Reprocessed Intravascular Ultrasound Catheter
Reprocessed ViewFlex Xtra ICE Catheter
| Applicant | Sterilmed, Inc., Plymouth MN, US |
| Decision | Substantially Equivalent, Nov 14, 2019 |
| Received | Feb 27, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K190478
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.