# K210235: Verrata PLUS Pressure Guide Wire

- Pathway: 510(k) (Special)
- Applicant: Volcano Corporation
- Decided: Apr 15, 2021 after 77 days
- Product code: DQX (Wire, Guide, Catheter)
- Device class: 2
- Regulation: 21 CFR 870.1330
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K131288 (2013). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161887: Verrata PLUS Pressure Guide Wire, 185 cm Straight Tip, Verrata PLUS Pressure Guide Wire, 185 cm J-Tip, Verrata PLUS Pressure Guide Wire, 300 cm Straight Tip, Verrata PLUS Pressure Guide Wire, 300 cm J-Tip, Volcano Corporation (2016) Summary page 4.

## Indications for use
The Verrata PLUS pressure guide wire is indicated for use to measure pressure in blood vessels, including both coronary and peripheral vessels, during diagnostic angiography and/or any interventional procedures. It can also be used to guide the positioning of a balloon dilatation catheter, as well as other interventional devices. Blood pressure measurements provide hemodynamic information for the diagnosis and treatment of blood vessel disease.

Source page: https://510kreport.com/device/K210235
Methodology: https://510kreport.com/methodology