# K230928: Vein360 Reprocessed Visions PV.018 Digital IVUS Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Vein 360, LLC
- Decided: Aug 25, 2023 after 144 days
- Product code: OWQ (Reprocessed Intravascular Ultrasound Catheter)
- 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: 2 generations back to K944004 (1995). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150442: Volcano Visions PV .018 Digital IVUS Catheter, Volcano Corporation (2015) Summary page 5.

## Indications for use
The Vein360 Reprocessed Visions PV .018 Digital IVUS Catheter is designed for use in the evaluation of vascular morphology in blood vessels of the peripheral vasculature by providing a cross-sectional image of such vessels. This device is not currently indicated for use in cerebral vessels. The Vein360 Reprocessed 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. The catheter is designed for use on adult patients (greater than 21 years of age).

Source page: https://510kreport.com/device/K230928
Methodology: https://510kreport.com/methodology