# K051337: Eagle Eye Gold Ivus Imaging Catheter, Model 85900/859XX; Volcano VH-Ivus System, Model 8049XX-001

- Pathway: 510(k) (Special)
- Applicant: Volcano Corporation
- Decided: Aug 18, 2005 after 87 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: 4 generations back to K934139 (1995). 7 ancestors in all.
47 later devices descend from it; 4 cite it directly.
2 of 55 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031346: Jovus Eagle Eye F/X 2.9F Ivus Catheter, Model 85900, Jomed, Inc. (2003) Summary page 1.
- K042188: Volcano Therapeutics, Inc. Volcano Ivus System, Volcano Therapeutics, Inc. (2004) Summary page 1.

## Most influential descendants
- K071554: Volcano S5/S5I Intravascular Imaging and Pressure System (2008), 28 descendants of its own
- K082229: S5/S5I Series Intravascular Imaging and Pressure System, Combomap Pressure and Flow System (2008), 25 descendants of its own
- K111706: Volcano S5IINTRAVASCULAR Imaging and Pressure System (2011), 24 descendants of its own
- K123898: Volcano S5/S5I Intravascular Ultrasound Imaging and Pressure System (2013), 21 descendants of its own
- K133323: Volcano Ifr Modality (2014), 18 descendants of its own

## Indications for use
The Eagle Eye Gold 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 Gold 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. Volcano VH IVUS System is intended to be used in conjunction with imaging catheters during diagnostic ultrasound imaging of the peripheral and coronary vasculature. The Volcano VH IVUS System is intended to semi-automatically visualize boundary features and perform spectral analysis of RF ultrasound signals of vascular featues that the user may wish to examine more closely during routine diagnostic ultrasound imaging examinations.

Source page: https://510kreport.com/device/K051337
Methodology: https://510kreport.com/methodology