# K111395: Primewire Prestige Plus

- Pathway: 510(k) (Special)
- Applicant: Volcano Corporation
- Decided: Aug 1, 2011 after 74 days
- Product code: DQX (Wire, Guide, Catheter)
- Device class: 2
- Regulation: 21 CFR 870.1330
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K823434 (1982). 15 ancestors in all.
13 later devices descend from it; 4 cite it directly.
0 of 29 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100930: Primewire Prestiage Pressure Guide Wire, Models 8185, 8185J, 8300, 8300J, Volcano Corporation (2010) Summary page 1.

## Most influential descendants
- K142598: Opto Wire and OptoMonitor System (2015), 12 descendants of its own
- K192340: OptoMonitor (2019), 7 descendants of its own
- K193620: OptoMonitor 3 (2020), 6 descendants of its own
- K152991: OptoWire Deux (2016), 6 descendants of its own
- K202943: OptoMonitor 3 (2020), 5 descendants of its own

## Recalls of this device
- Jun 4, 2015 · Class II · Z-1845-2015: 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 PrimeWire PRESTIGE® Plus Pressure Guide Wire Device 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/K111395
Methodology: https://510kreport.com/methodology