510(k) K254149 · OWQ Reprocessed Intravascular Ultrasound Catheter
Reprocessed AcuNav CRYSTAL Ultrasound Catheter 9F x 90 CM, For Use on Siemens System (R11510825); Reprocessed AcuNav CRYSTAL Ultrasound Catheter 9F x 90 CM, For Use on GE System (R11657484); Reprocessed SOUNDSTAR CRYSTAL Ultrasound Catheter 9F x 90 CM, For Use on Siemens System (R11510826); Repro
| Applicant | Sterilmed, Inc., Plymouth MN, US |
| Decision | Substantially Equivalent, Jun 29, 2026 |
| Received | Dec 22, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K254149
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.