K253399
- 510(k) number
- K253399
- Device name
- Visions® PV .014P RX Digital IVUS Catheter ; Visions® PV .018 Digital IVUS Catheter
- Applicant
- Volcano Corporation (Dba Philips Image Guided Therapy Device CA · US
- Product code
- OBJ — Catheter, Ultrasound, Intravascular
- Decision date
- 2025-10-28
- Date received
- 2025-09-30
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 3.0 MB · U.S. public domain
Also available from FDA: K253399.pdf
Official FDA record: K253399
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.