# K143701: Eagle Eye Platinum Catheter, Eagle Eye Platinum Short Tip Catheter, Visions PV .014 Platinum

- Pathway: 510(k) (Traditional)
- Applicant: Volcano Corporation
- Decided: Aug 26, 2015 after 245 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: 8 generations back to K934139 (1995). 11 ancestors in all.
10 later devices descend from it; 5 cite it directly.
1 of 22 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 4.
- K120697: Eagle Eye Platinum ST Catheter, Volcano Corporation (2012) Summary page 4.

## Most influential descendants
- 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
- K191175: ACIST Kodama Intravascular Ultrasound Catheter, ACIST HDi System (2019), 1 descendant of its own

## Indications for use
The Eagle Eye® Platinum (EEP) Digital IVUS Catheter Line, including the Eagle Eye Platinum catheter, Eagle Eye Platinum ST catheter and the PV.014P catheter, 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. These devices are not currently indicated for use in the cerebral vessels. The Eagle Eye® Platinum (EEP) Digital IVUS Catheter Line is 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/K143701
Methodology: https://510kreport.com/methodology