# K042996: Combowire Pressure and Flow Guide Wire, Combotip Pressure and Flow Guide Wire

- Pathway: 510(k) (Special)
- Applicant: Volcano Therapeutics, Inc.
- Decided: Nov 24, 2004 after 23 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: 3 generations back to K823434 (1982). 14 ancestors in all.
29 later devices descend from it; 1 cites it directly.
1 of 44 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021219: Smartwire/Smartmap Pressure System, Jomed, Inc. (2002) Summary page 1.
- K905411: Flowire and Flomap, Cardio Metrics, Inc. (1991) Summary page 1.
- K912776: Cardiometrics Flowire/Flomap Doppler Ultrasound, Cardio Metrics, Inc. (1992) Summary page 1.
- K921563: Cardiometrics Flowire/Flomap System, Cardio Metrics, Inc. (1992) Summary page 1.
- K972762: Cardiometrics Flowire 300 and XT 300 Doppler Guide Wires, Cardio Metrics, Inc. (1997) Summary page 1.

## Most influential descendants
- K071554: Volcano S5/S5I Intravascular Imaging and Pressure System (2008), 28 descendants of its own
- K082229: S5/S5I Series Intravascular Imaging and Pressure System, Combomap Pressure and Flow System (2008), 25 descendants of its own
- K111706: Volcano S5IINTRAVASCULAR Imaging and Pressure System (2011), 24 descendants of its own
- K123898: Volcano S5/S5I Intravascular Ultrasound Imaging and Pressure System (2013), 21 descendants of its own
- K133323: Volcano Ifr Modality (2014), 18 descendants of its own

## Indications for use
ComboWireTM and ComboTipTM Pressure/Flow Guide Wire is indicated for use to measure simultaneous pressure and blood flow velocities in blood vessels, including coronary and peripheral vessels, during diagnostic angiography and/or interventional procedures.

Source page: https://510kreport.com/device/K042996
Methodology: https://510kreport.com/methodology