510(k) K253399 · OBJ Catheter, Ultrasound, Intravascular
Visions® PV .014P RX Digital IVUS Catheter ; Visions® PV .018 Digital IVUS Catheter
| Applicant | Volcano Corporation (Dba Philips Image Guided Therapy Device, San Diego CA, US |
| Decision | Substantially Equivalent, Oct 28, 2025 |
| Received | Sep 30, 2025 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K253399
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.