# K080891: Revolution 45MHZ Ivus Imaging Catheter

- Pathway: 510(k) (Special)
- Applicant: Volcano Corporation
- Decided: May 12, 2008 after 42 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: 3 generations back to K921879 (1992). 6 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050995: Revolution 45 MHZ Rotational Ivus Imaging Catheter, Volcano Corporation (2005) Summary page 1.

## Most influential descendants
- K122826: Preview Forward-Looking Ivus Catheter and Laptop System; Preview Catheter Model 87000; Pimf Model 87-Pimf; Laptop System (2013), 1 descendant of its own
- K160583: REFINITY Rotational IVUS Catheter, REFINITY Rotational IVUS Catheter, Short Tip (2016), 0 descendants of its own
- K132659: Volcano Preview Forward-Looking Ivus System (2013), 0 descendants of its own

## Indications for use
The Revolution 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.

Source page: https://510kreport.com/device/K080891
Methodology: https://510kreport.com/methodology