# K100930: Primewire Prestiage Pressure Guide Wire, Models 8185, 8185J, 8300, 8300J

- Pathway: 510(k) (Special)
- Applicant: Volcano Corporation
- Decided: Apr 30, 2010 after 25 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: 4 generations back to K823434 (1982). 14 ancestors in all.
14 later devices descend from it; 1 cites 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)
- K021219: Smartwire/Smartmap Pressure System, Jomed, Inc. (2002). Our reading of the summary gave K021209, which is not a number in FDA’s lists. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “SmartWire/SmartMap Pressure System”.
- K070487: Smartwire Pressure Guide Wire, Model 66XX, Volcano Corporation (2007) Summary page 1.
- (no number) PrimeWire Pressure Guide Wire (June 26, 2008): named in the summary without a submission number
- (no number) PrimeWire Pressure Guide Wire (April 6, 2009): named in the summary without a submission number

## Most influential descendants
- K111395: Primewire Prestige Plus (2011), 13 descendants of its own
- 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

## Indications for use
The PrimeWire PRESTIGE TMPressure 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/K100930
Methodology: https://510kreport.com/methodology