510(k) K223077 ยท OBJ Catheter, Ultrasound, Intravascular
ViewFlex Xtra ICE Catheter
| Applicant | Irvine Biomedical, A St. Jude Medical Company, Irvine CA, US |
| Decision | Substantially Equivalent, Dec 7, 2022 |
| Received | Sep 30, 2022 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K223077
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.