Home / 510(k) Clearances / K900860

510(k) K900860

PERFUSION MONITOR by Cardio Metrics, Inc. — Product Code DTY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 14, 1990
Date Received
February 23, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Sensor, Blood-Gas, In-Line, Cardiopulmonary Bypass
Device Class
Class II
Regulation Number
870.4410
Review Panel
CV
Submission Type

Other clearances by Cardio Metrics, Inc.

  • K972762 — CARDIOMETRICS FLOWIRE 300 AND XT 300 DOPPLER GUIDE WIRES (October 14, 1997)
  • K965140 — CARDIOMETRICS WAVEWIRE/WAVEMAP PRESSURE SYSTEM (August 18, 1997)
  • K951567 — CARDIOMETICS FLOWIRE, SMARTWIRE DOPPLER GUIDE WIRE (October 25, 1996)
  • K961777 — ACCUTRAC XT INTRAVASCULAR GUIDE WIRE (FLOPPY) MODEL 2403/(FLEX) MODEL 2404 (July 31, 1996)
  • K955551 — CARDI0METRICS FLOW WIRE XT DOPPLER GUIDE MODEL 1403, 1404 (February 28, 1996)
  • K954913 — CARDIOMETRICS ACCUTRAC INTRAVASCULAR GUIDE WIRE (MODIFICATION) (November 7, 1995)
  • K952562 — CARDIOMETRICS ACCUTRAC INTRAVASCULAR GUIDE WIRE (August 29, 1995)
  • K943022 — CARDIOMETRICS FLOWIRE DOPPLER GUIDE WIRE (September 19, 1994)
  • K940984 — CARDIOMETRICS DUALFLOW SWITCH BOX (August 18, 1994)
  • K933320 — CARDIOMETRICS FLOMAP AND FLOMOD ULTRASOUND INSTRUMENT (August 17, 1994)

Other clearances for product code DTY

  • K093650 — BIOTREND OXYGEN SATURATION AND HEMATOCRIT SYSTEM (February 17, 2010)
  • K963698 — CM02 CUVETTE, 1/2, CM02 CUVETTE, 3/8 AND CM02 CUVETTE, 1/4 (March 20, 1997)
  • K954501 — BIOTREND OXYGEN SATURATION & HEMATOCRIT SYSTEM (January 16, 1996)
  • K902654 — CDI (TM) SYSTEM 100 MONITORING SYSTEM (November 5, 1990)
  • K864703 — MODIFIED GAS-STAT(TM) MONITORING SYSTEM (February 19, 1987)
  • K840749 — GAST STAT MONITORING SYSTEM (April 17, 1984)
  • K822000 — EXTRACORPOREAL BLOOD GAS SYSTEM (December 22, 1982)