510(k) K231621 ยท OWQ Reprocessed Intravascular Ultrasound Catheter
Reprocessed ViewFlex Xtra ICE Catheter (D087031)
| Applicant | Stryker Sustainability Solutions, Tempe AZ, US |
| Decision | Substantially Equivalent, Jul 25, 2023 |
| Received | Jun 2, 2023 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K231621
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.