# K951567: Cardiometics Flowire, Smartwire Doppler Guide Wire

- Pathway: 510(k) (Traditional)
- Applicant: Cardio Metrics, Inc.
- Decided: Oct 25, 1996 after 570 days
- Product code: ITX (Transducer, Ultrasonic, Diagnostic)
- Device class: 2
- Regulation: 21 CFR 892.1570
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device 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) Cardiometrics FloWire Doppler Guide Wire: named in the summary without a submission number
- (no number) Cardiometrics SmartWire Doppler Guide Wire: named in the summary without a submission number

## Indications for use
The FloWire Doppler Guide Wires and the FloMap Ultrasound Instrument measure blood velocities in peripheral and coronary arteries. The FloWire/FloMap System are intended for use in conjunction with diagnostic procedures such as peripheral and coronary angiography and for interventional procedures such as balloon angioplasty, as well as other interventional procedures which utilize a guide wire in the peripheral and coronary vasculature. The SmartWire Doppler Guide Wire and SmartMap Ultrasound Instrument are intended for use in the cerebral vasculature to measure blood flow velocities during diagnostic angiography and/or any interventional procedures.

Source page: https://510kreport.com/device/K951567
Methodology: https://510kreport.com/methodology