# K071660: Visions PV 8.2 Intravascular Ultrasound Imaging Catheter, Model 88900

- Pathway: 510(k) (Special)
- Applicant: Volcano Corporation
- Decided: Aug 31, 2007 after 74 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: 1 generation back to K982329 (1999). 1 ancestor in all.
4 later devices descend from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K982329: Visions 8.2F PV Ultrasonic Imaging Catheter (Model 88900), Endosonics Corp. (1999) Summary page 1.

## Most influential descendants
- K121273: Visions PV .035 Ditital Ivus Catheter (2012), 3 descendants of its own
- K153094: Visions PV .035 Digital IVUS Catheter (2015), 2 descendants of its own
- K230584: Vein360 Reprocessed Visions PV.035 Digital IVUS Catheter (2023), 0 descendants of its own
- K181126: Reprocessed Visions PV .035 Digital IVUS Catheter (2019), 0 descendants of its own

## Indications for use
The Visions PV 8.2F catheters are designed for use in the evaluation of vascular morphology in blood vessels of the peripheral vasculature by providing a cross-sectional image of such vessels. The Visions PV 8.2F 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 and dimensional measurements from the image.

Source page: https://510kreport.com/device/K071660
Methodology: https://510kreport.com/methodology