CARDIOMETICS FLOWIRE, SMARTWIRE DOPPLER GUIDE WIRE

CARDIOMETICS FLOWIRE, SMARTWIRE DOPPLER GUIDE WIRE is an FDA 510(k)-cleared medical device (K951567) manufactured by Cardio Metrics, Inc.. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 24, 1996. Regulation: 8.