Visions® PV .014P RX Digital IVUS Catheter; Visions® PV .018 Digital IVUS Catheter— 510(k) K253399

Name: FDA 510(k) clearance K253399
Creator: U.S. Food and Drug Administration
Published: 2025-10-28

Substantially Equivalent

Volcano Corporation (Dba Philips Image Guided Therapy Device

FDA 510(k) clearance K253399 for Visions® PV .014P RX Digital IVUS Catheter; Visions® PV .018 Digital IVUS Catheter, Substantially Equivalent on 2025-10-28. Applicant: Volcano Corporation (Dba Philips Image Guided Therapy Device. Device class: 2.

Clearance details

Device name as filed: Visions® PV .014P RX Digital IVUS Catheter ; Visions® PV .018 Digital IVUS Catheter
Applicant: Volcano Corporation (Dba Philips Image Guided Therapy Device
Product code: Code OBJ
Device class: Class 2
Regulation: 21 CFR 870.1200
Advisory panel: Cardiovascular
Date received: 2025-09-30
Decision date: 2025-10-28
Decision: Substantially Equivalent
Clearance type: Special
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code OBJ

product code OBJ

Death: 38
Injury: 634
Malfunction: 3,453
Total: 4,125

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.