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Cardio Metrics, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
23
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K972762CARDIOMETRICS FLOWIRE 300 AND XT 300 DOPPLER GUIDE WIRESOctober 14, 1997
K965140CARDIOMETRICS WAVEWIRE/WAVEMAP PRESSURE SYSTEMAugust 18, 1997
K951567CARDIOMETICS FLOWIRE, SMARTWIRE DOPPLER GUIDE WIREOctober 25, 1996
K961777ACCUTRAC XT INTRAVASCULAR GUIDE WIRE (FLOPPY) MODEL 2403/(FLEX) MODEL 2404July 31, 1996
K955551CARDI0METRICS FLOW WIRE XT DOPPLER GUIDE MODEL 1403, 1404February 28, 1996
K954913CARDIOMETRICS ACCUTRAC INTRAVASCULAR GUIDE WIRE (MODIFICATION)November 7, 1995
K952562CARDIOMETRICS ACCUTRAC INTRAVASCULAR GUIDE WIREAugust 29, 1995
K943022CARDIOMETRICS FLOWIRE DOPPLER GUIDE WIRESeptember 19, 1994
K940984CARDIOMETRICS DUALFLOW SWITCH BOXAugust 18, 1994
K933320CARDIOMETRICS FLOMAP AND FLOMOD ULTRASOUND INSTRUMENTAugust 17, 1994
K941485CARDIOMETRICS FLOWIRE DOPPLER GUIDE WIRESMay 31, 1994
K932536CARDIOMETRICS FLOWIRE & FLOMAPSeptember 28, 1993
K925524CARDIOMETRICS SMARTWIRE(TM)/FLOMAP(R)August 23, 1993
K921563CARDIOMETRICS FLOWIRE/FLOMAP SYSTEMJuly 1, 1992
K912776CARDIOMETRICS FLOWIRE/FLOMAP DOPPLER ULTRASOUNDJanuary 9, 1992
K905411FLOWIRE AND FLOMAPMarch 29, 1991
K900860PERFUSION MONITORAugust 14, 1990
K901733MODIFIED FLOCATH PULMONARY ARTERY CATHETERJuly 16, 1990
K882593MODIFIED CONTINUOUS CARDIAC OUTPUT MONITOR SYSTEMAugust 29, 1988
K870150CONTINUOUS CARDIAC OUTPUT MONITORING SYSTEMAugust 7, 1987