Medical Device Manufacturer · US , Houston , TX

Cardio Metrics, Inc. - FDA 510(k) Cleared Devices

23 submissions · 23 cleared · Since 1986

Recent clearances: CARDIOMETRICS FLOWIRE 300 AND XT 300 DOPPLER GUIDE WIRES, CARDIOMETRICS WAVEWIRE/WAVEMAP PRESSURE SYSTEM, CARDIOMETICS FLOWIRE, SMARTWIRE DOPPLER GUIDE WIRE

23

Total

23

Cleared

0

Denied

FDA 510(k) Regulatory Record - Cardio Metrics, Inc. Cardiovascular ✕

17 devices

1-12 of 17

Cleared Oct 14, 1997

CARDIOMETRICS FLOWIRE 300 AND XT 300 DOPPLER GUIDE WIRES

Cardiovascular · 82d

Cleared Aug 18, 1997

CARDIOMETRICS WAVEWIRE/WAVEMAP PRESSURE SYSTEM

Cardiovascular · 238d

Cleared Jul 31, 1996

ACCUTRAC XT INTRAVASCULAR GUIDE WIRE (FLOPPY) MODEL 2403/(FLEX) MODEL 2404

Cardiovascular · 85d

Cleared Feb 28, 1996

CARDI0METRICS FLOW WIRE XT DOPPLER GUIDE MODEL 1403, 1404

Cardiovascular · 85d

Cleared Nov 07, 1995

CARDIOMETRICS ACCUTRAC INTRAVASCULAR GUIDE WIRE (MODIFICATION)

Cardiovascular · 35d

Cleared Aug 29, 1995

CARDIOMETRICS ACCUTRAC INTRAVASCULAR GUIDE WIRE

Cardiovascular · 88d

Cleared Sep 19, 1994

CARDIOMETRICS FLOWIRE DOPPLER GUIDE WIRE

Cardiovascular · 87d

Cleared Aug 18, 1994

CARDIOMETRICS DUALFLOW SWITCH BOX

Cardiovascular · 170d

Cleared May 31, 1994

CARDIOMETRICS FLOWIRE DOPPLER GUIDE WIRES

Cardiovascular · 64d

Cleared Aug 23, 1993

CARDIOMETRICS SMARTWIRE(TM)/FLOMAP(R)

Cardiovascular · 294d

Cleared Mar 29, 1991

FLOWIRE AND FLOMAP

Cardiovascular · 116d

Cleared Aug 14, 1990

PERFUSION MONITOR

Cardiovascular · 172d