# K972762: Cardiometrics Flowire 300 and XT 300 Doppler Guide Wires

- Pathway: 510(k) (Traditional)
- Applicant: Cardio Metrics, Inc.
- Decided: Oct 14, 1997 after 82 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
No predicates in its family tree.
31 later devices descend from it; 2 cite it directly.
1 of 32 devices in its family (counting itself) has 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) Cardiometrics FloWire Doppler Guide Wire with CINCH® extension: named in the summary without a submission number
- (no number) Cardiometrics FloWire XT Doppler Guide Wire with CINCH® extension: named in the summary without a submission number

## Most influential descendants
- K042996: Combowire Pressure and Flow Guide Wire, Combotip Pressure and Flow Guide Wire (2004), 29 descendants of its own
- 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

## Recalls of this device
- Oct 6, 2009 · Not classified · Z-0935-2012: Reports of no signal displayed on the monitor when FloWire Doppler Guide wires were connected to the Combomap.

## Indications for use
The Cardiometrics FloWire 300 Doppler Guide Wire and the Cardiometrics FloWire XT 300 Doppler Guide Wires are intended for use in all blood vessels, including both coronary and peripheral arteries, to measure blood flow velocities during diagnostic angiography and/or interventional procedures. The FloWire may be used to guide the positioning of a balloon dilatation catheter, as well as other interventional devices. Blood flow velocity measurements are obtained to provide hemodynamic information for the diagnosis and treatment of coronary or peripheral artery disease.

Source page: https://510kreport.com/device/K972762
Methodology: https://510kreport.com/methodology