# K210655: Reprocessed Eagle Eye Platinum RX Digital IVUS Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Innovative Health, LLC
- Decided: May 25, 2022 after 447 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: 9 generations back to K934139 (1995). 12 ancestors in all.
1 later device descends from it; 1 cites it directly.
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 5.

## Most influential descendants
- K223026: NES Reprocessed Eagle Eye Platinum RX Digital IVUS Catheter (2023), 0 descendants of its own

## Indications for use
The Reprocessed Eagle Eye Platinum RX Digital IVUS Catheters are 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 Reprocessed Eagle Eye Platinum 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/K210655
Methodology: https://510kreport.com/methodology