# K131288: Verrata Pressure Guide Wire

- Pathway: 510(k) (Special)
- Applicant: Volcano Corporation
- Decided: Jun 21, 2013 after 46 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
No predicates in its family tree.
4 later devices descend from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Volcano PrimeWire PRESTIGE® Plus Pressure Guide Wire: named in the summary without a submission number

## Most influential descendants
- 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 (2016), 3 descendants of its own
- K192886: OmniWire Pressure Guide Wire, 185 cm Straight Tip, OmniWire Pressure Guide Wire, 185 cm J-Tip (2020), 1 descendant of its own
- K210235: Verrata PLUS Pressure Guide Wire (2021), 0 descendants of its own
- K202543: OmniWire Pressure Guide Wire, 185 cm Straight Tip, OmniWire Pressure Guide Wire, 185 cm J-Tip (2020), 0 descendants of its own

## Indications for use
The Verrata™ 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. Blood pressure measurements provide hemodynamic information for the diagnosis and treatment of blood vessel disease.

Source page: https://510kreport.com/device/K131288
Methodology: https://510kreport.com/methodology