# K253399: Visions® PV .014P RX Digital IVUS Catheter ; Visions® PV .018 Digital IVUS Catheter

- Pathway: 510(k) (Special)
- Applicant: Volcano Corporation (Dba Philips Image Guided Therapy Device
- Decided: Oct 28, 2025 after 28 days
- Product code: OBJ (Catheter, Ultrasound, Intravascular)
- Device class: 2
- Regulation: 21 CFR 870.1200
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K934139 (1995). 15 ancestors in all.
No later device cites it as a predicate yet.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K152829: Visions PV.014P RX Digital IVUS Catheter, Volcano Corporation (2015) Summary page 6.
- K150442: Volcano Visions PV .018 Digital IVUS Catheter, Volcano Corporation (2015) Summary page 6.

## Indications for use
Visions® PV.014P RX Digital IVUS Catheter: The Visions® PV.014P RX Digital IVUS Catheter is designed for use in the evaluation of vascular morphology in blood vessels of the coronary and peripheral vasculature by providing a cross-sectional image of such vessels. This device is not currently indicated for use in the cerebral vessels. The Visions® PV.014P RX Digital IVUS Catheter is designed for use as an adjunct to conventional angiographic procedures to provide an image of the vessel lumen and wall structures. Visions® PV .018 Digital IVUS Catheter: The Visions® PV .018 Digital IVUS Catheter is designed for use in the evaluation of vascular morphology in blood vessels of the coronary and peripheral vasculature by providing a cross-sectional image of such vessels. This device is not currently indicated for use in cerebral vessels. The Visions® PV .018 Digital IVUS Catheter is designed for use as an adjunct to conventional angiographic procedures to provide an image of the vessel lumen and wall structures.

Source page: https://510kreport.com/device/K253399
Methodology: https://510kreport.com/methodology