Cardiometrics Wavewire/Wavemap Pressure System

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K965140 ↗

FDA Product Code

DQX

Device Class

Class II

Regulation

21 CFR Part 870.1330

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Cardiometrics Dualflow Switch Box

  Class II

  FDA 510(k) K940984 Active Cleared 18 Aug 1994

• Continuous Cardiac Output Monitoring System

  Class II

  FDA 510(k) K870150 Active Cleared 7 Aug 1987

• Cardiometrics Smartwire(Tm)/Flomap(R)

  Class II

  FDA 510(k) K925524 Active Cleared 23 Aug 1993

• Cardiometrics Flowire/Flomap Doppler Ultrasound

  Class II

  FDA 510(k) K912776 Active Cleared 9 Jan 1992

• Perfusion Monitor

  Class II

  FDA 510(k) K900860 Active Cleared 14 Aug 1990

• Cardiometrics Flomap and Flomod Ultrasound Instrument

  Class II

  FDA 510(k) K933320 Active Cleared 17 Aug 1994

See all devices from Cardio Metrics, Inc. →