# K232584: Vein360 Reprocessed Visions PV.014P Rx Digital IVUS Catheter, Vein360 Reprocessed Eagle Eye Platinum Rx Digital IVUS Catheter, Vein360 Reprocessed Eagle Eye Platinum ST Rx Digital IVUS Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Vein 360, LLC
- Decided: Oct 24, 2023 after 60 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: 10 generations back to K934139 (1995). 13 ancestors in all.
No later device cites it as a predicate yet.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K143701: Eagle Eye Platinum Catheter, Eagle Eye Platinum Short Tip Catheter, Visions PV .014 Platinum, Volcano Corporation (2015) Summary page 6.
- K152829: Visions PV.014P RX Digital IVUS Catheter, Volcano Corporation (2015) Summary page 6.

## Indications for use
The Vein360 Reprocessed Visions® PV .014P RX (85910P), Visions® PV.014P RX (014R), Eagle Eye Platinum RX, and Eagle Eye Platinum ST RX Digital IVUS catheters are all 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. These devices are not currently indicated for use in the cerebral vessels. The Vein360 Reprocessed Visions® PV .014P RX (85910P), Visions® PV.014p RX (014R), Eagle Eye Platinum RX, and Eagle Eye Platinum ST RX Digital IVUS catheters are 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/K232584
Methodology: https://510kreport.com/methodology