510(k) K222217 ยท OWQ Reprocessed Intravascular Ultrasound Catheter
ViewFlex Xtra Reprocessed ICE Catheter
| Applicant | ABBOTT MEDICAL, Minnetonka MN, US |
| Decision | Substantially Equivalent, Dec 19, 2022 |
| Received | Jul 25, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K222217
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.