# K132659: Volcano Preview Forward-Looking Ivus System

- Pathway: 510(k) (Special)
- Applicant: Volcano Corporation
- Decided: Sep 27, 2013 after 32 days
- Product code: DQY (Catheter, Percutaneous)
- Device class: 2
- Regulation: 21 CFR 870.1250
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K934139 (1995). 51 ancestors in all.
No later device cites it as a predicate yet.
0 of 52 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122826: Preview Forward-Looking Ivus Catheter and Laptop System; Preview Catheter Model 87000; Pimf Model 87-Pimf; Laptop System, Volcano Corporation (2013) Summary page 1.
- K123898: Volcano S5/S5I Intravascular Ultrasound Imaging and Pressure System, Volcano Corporation (2013) Summary page 1.

## Indications for use
The PreViews' Forward-Looking IVUS System is indicated for use to facilitate the intraluminal placement of guidewires in the peripheral vasculature prior to further percutaneous intervention and to support guidewires in accessing discrete regions of the peripheral vasculature, to assess vessel morphology, assess the position of the catheter tip within the vessel lumen, and to facilitate placement and exchanges of guidewires and other interventional devices compatible with 0.0 14" guidewire lumens. The Previews Forward-Looking IVUS System is designed as an adjunct to conventional angiographic procedures to provide a forward-looking image of the vessel lumen and wall structures. The PreView® Forward-Looking IVUS System is not indicated for use for imaging with the exposed rotating tip inside a stent. This device is not indicated for use in coronary or cerebral vessels.

Source page: https://510kreport.com/device/K132659
Methodology: https://510kreport.com/methodology