510(k) K951567

CARDIOMETICS FLOWIRE, SMARTWIRE DOPPLER GUIDE WIRE by Cardio Metrics, Inc. — Product Code ITX

K951567 is an FDA 510(k) premarket notification submitted by Cardio Metrics, Inc. for the device "CARDIOMETICS FLOWIRE, SMARTWIRE DOPPLER GUIDE WIRE". The FDA issued a decision of Substantially Equivalent on October 25, 1996. The device falls under product code ITX (Transducer, Ultrasonic, Diagnostic), a Class II device regulated under 21 CFR 892.1570. Cardio Metrics, Inc. has at least 10 other 510(k) clearances on record.