# K153094: Visions PV .035 Digital IVUS Catheter

- Pathway: 510(k) (Special)
- Applicant: Volcano Corporation
- Decided: Dec 31, 2015 after 66 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: 3 generations back to K982329 (1999). 3 ancestors in all.
2 later devices descend from it; 2 cite 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)
- K121273: Visions PV .035 Ditital Ivus Catheter, Volcano Corporation (2012) Summary page 4.

## Most influential descendants
- 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

## Recalls of this device
- May 13, 2022 · Class III · Z-1302-2022: Digital IVUS catheter instructions for use ( IFU) do not contain contrainidications
- Oct 17, 2018 · Class II · Z-0727-2019: Visions PV .035 Intravascular Ultrasound (IVUS) Catheters (catalog number 88901 adnd81234) due to the potential inability to pass the guidewire through the y-port of the catheter.

## Indications for use
The Visions® PV .035 Digital IVUS Catheter is 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. This device is not currently indicated for use in cerebral vessels. The Visions® PV .035 Digital IVUS Catheter is 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/K153094
Methodology: https://510kreport.com/methodology