# K073473: Eagle Eye Gold Ivus Imaging Catheter, Model 85900, Avabar F/X Ivus Imaging Catheter, Model 85700

- Pathway: 510(k) (Special)
- Applicant: Volcano Corporation
- Decided: Jan 14, 2008 after 34 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: 5 generations back to K934139 (1995). 8 ancestors in all.
14 later devices descend from it; 1 cites 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)
- K051337: Eagle Eye Gold Ivus Imaging Catheter, Model 85900/859XX; Volcano VH-Ivus System, Model 8049XX-001, Volcano Corporation (2005) Summary page 1.
- K000820: Avanar F/X 2.9F Intravascular Ultrasound Imaging Catheter, Model 85700, Endosonics Corp. (2000) Summary page 1.

## Most influential descendants
- K092596: Eagle Eye Platinum Digital Ivus Catheter (2009), 13 descendants of its own
- 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

## 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. The Avanar F/X 2.9F Catheter is 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 Avanar catheter 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/K073473
Methodology: https://510kreport.com/methodology