# K223026: NES Reprocessed Eagle Eye Platinum RX Digital IVUS Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Northeast Scientific, Inc.
- Decided: Feb 3, 2023 after 127 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: 11 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)
- K210655: Reprocessed Eagle Eye Platinum RX Digital IVUS Catheter, Innovative Health, LLC (2022) Summary page 5.
- K200195: NES Reprocessed Visions PV .014P RX Digital IVUS Catheter, Northeast Scientific, Inc. (2020) Summary page 5.

## Indications for use
The NES 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 NES 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/K223026
Methodology: https://510kreport.com/methodology