# K120697: Eagle Eye Platinum ST Catheter

- Pathway: 510(k) (Special)
- Applicant: Volcano Corporation
- Decided: Apr 5, 2012 after 29 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: 7 generations back to K934139 (1995). 10 ancestors in all.
12 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)
- K092596: Eagle Eye Platinum Digital Ivus Catheter, Volcano Corporation (2009) Summary page 1.

## Most influential descendants
- 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
- K200410: Reconnaissance PV .018 OTW Digital IVUS Catheter (2020), 1 descendant of its own

## Indications for use
The Eagle Eye® Platinum ST 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 ST ultrasound imaging 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/K120697
Methodology: https://510kreport.com/methodology