510(k) K231588 · OWQ Reprocessed Intravascular Ultrasound Catheter
ViewFlex Eco Reprocessed ICE Catheter
| Applicant | ABBOTT MEDICAL, Minnetonka MN, US |
| Decision | Substantially Equivalent, Jun 30, 2023 |
| Received | Jun 1, 2023 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K231588
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.