510(k) K261696 ยท OBJ Catheter, Ultrasound, Intravascular
ACUNAV Luxera 4D ICE Catheter
| Applicant | Siemens Medical Solutions USA, Inc., Issaquah WA, US |
| Decision | Substantially Equivalent, Sep 10, 2026 |
| Received | May 22, 2026 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K261696
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.