# K092596: Eagle Eye Platinum Digital Ivus Catheter

- Pathway: 510(k) (Abbreviated)
- Applicant: Volcano Corporation
- Decided: Dec 10, 2009 after 108 days
- Product code: OBJ (Catheter, Ultrasound, Intravascular)
- 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: 6 generations back to K934139 (1995). 9 ancestors in all.
13 later devices descend from it; 2 cite it directly.
1 of 23 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073473: Eagle Eye Gold Ivus Imaging Catheter, Model 85900, Avabar F/X Ivus Imaging Catheter, Model 85700, Volcano Corporation (2008) Summary page 1.

## Most influential descendants
- K120697: Eagle Eye Platinum ST Catheter (2012), 12 descendants of its own
- K143701: Eagle Eye Platinum Catheter, Eagle Eye Platinum Short Tip Catheter, Visions PV .014 Platinum (2015), 10 descendants of its own
- K152829: Visions PV.014P RX Digital IVUS Catheter (2015), 4 descendants of its own
- K210655: Reprocessed Eagle Eye Platinum RX Digital IVUS Catheter (2022), 1 descendant of its own
- K200195: NES Reprocessed Visions PV .014P RX Digital IVUS Catheter (2020), 1 descendant of its own

## Indications for use
Eagle Eye® Platinum 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 Eagle Eye® Platinum 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/K092596
Methodology: https://510kreport.com/methodology