# K150442: Volcano Visions PV .018 Digital IVUS Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Volcano Corporation
- Decided: Sep 4, 2015 after 196 days
- Product code: OBJ (Catheter, Ultrasound, Intravascular)
- Device class: 2
- Regulation: 21 CFR 870.1200
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K944004 (1995). 1 ancestor in all.
5 later devices descend from it; 4 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K944004: Visions 2.9F Ultrasonic Imaging Catheter (Model 84300), Endosonics Corp. (1995) Summary page 4.

## Most influential descendants
- K200410: Reconnaissance PV .018 OTW Digital IVUS Catheter (2020), 1 descendant of its own
- K253399: Visions® PV .014P RX Digital IVUS Catheter ; Visions® PV .018 Digital IVUS Catheter (2025), 0 descendants of its own
- K250592: NES Reprocessed Visions PV .018 Digital IVUS Catheter (R-86700) (2025), 0 descendants of its own
- K233948: Provisio™ SLT IVUS™ System (2024), 0 descendants of its own
- K230928: Vein360 Reprocessed Visions PV.018 Digital IVUS Catheter (2023), 0 descendants of its own

## Recalls of this device
- Jun 13, 2025 · Class II · Z-2221-2025: Reports of IVUS catheter and guide wire entanglement during radial-to-peripheral procedures, due to catheter use without appropriate sheath and/or guide catheter, which may require further interventio

## Indications for use
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/K150442
Methodology: https://510kreport.com/methodology