# K121273: Visions PV .035 Ditital Ivus Catheter

- Pathway: 510(k) (Abbreviated)
- Applicant: Volcano Corporation
- Decided: Sep 10, 2012 after 136 days
- Product code: OBJ (Catheter, Ultrasound, Intravascular)
- Device class: 2
- Regulation: 21 CFR 870.1200
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K982329 (1999). 2 ancestors in all.
3 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)
- K071660: Visions PV 8.2 Intravascular Ultrasound Imaging Catheter, Model 88900, Volcano Corporation (2007) Summary page 1.

## Most influential descendants
- 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

## Recalls of this device
- May 13, 2022 · Class III · Z-1301-2022: Digital IVUS catheter instructions for use ( IFU) do not contain contrainidications
- Oct 17, 2018 · Class II · Z-0726-2019: 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.
- Jun 4, 2015 · Class II · Z-1844-2015: During a relabeling procedure at the manufacturing facility, the products were labeled with a shelf life in accordance with the date of the relabeling and not in accordance with the original shelf lif

## Indications for use
The Visions PV .035 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 .035 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/K121273
Methodology: https://510kreport.com/methodology