510(k) K250955 ยท OBJ Catheter, Ultrasound, Intravascular
XC11 ICE System, USA
| Applicant | Yorlabs, Inc., Carlsbad CA, US |
| Decision | Substantially Equivalent, Oct 22, 2025 |
| Received | Mar 31, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K250955
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.