# K160583: REFINITY Rotational IVUS Catheter, REFINITY Rotational IVUS Catheter, Short Tip

- Pathway: 510(k) (Traditional)
- Applicant: Volcano Corporation
- Decided: Oct 26, 2016 after 239 days
- Product code: OBJ (Catheter, Ultrasound, Intravascular)
- Device class: 2
- Regulation: 21 CFR 870.1200
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K934139 (1995). 18 ancestors in all.
No later device cites it as a predicate yet.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080891: Revolution 45MHZ Ivus Imaging Catheter, Volcano Corporation (2008) Summary page 4.
- K120697: Eagle Eye Platinum ST Catheter, Volcano Corporation (2012) Summary page 4.

## Recalls of this device
- Mar 29, 2017 · Class II · Z-1776-2017: High complaint rates of kinking near the junction of the proximal shaft to telescope section of the catheter. Kinking could result in disruption of normal clinical workflow or loss of imaging.
- Mar 29, 2017 · Class II · Z-1775-2017: High complaint rates of kinking near the junction of the proximal shaft to telescope section of the catheter. Kinking could result in disruption of normal clinical workflow or loss of imaging.

## Indications for use
The REFINITY (or REFINITY ST) Rotational IVUS Catheter (REFINITY or REFINITY ST catheter) is intended for the intravascular ultrasound examination of coronary arteries. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal interventional procedures. REFINITY (or REFINITY ST) 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/K160583
Methodology: https://510kreport.com/methodology