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510(k) K822000

EXTRACORPOREAL BLOOD GAS SYSTEM by Cardiovascular Devices, Inc. — Product Code DTY

K822000 is an FDA 510(k) premarket notification submitted by Cardiovascular Devices, Inc. for the device "EXTRACORPOREAL BLOOD GAS SYSTEM". The FDA issued a decision of Substantially Equivalent on December 22, 1982. The device falls under product code DTY (Sensor, Blood-Gas, In-Line, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4410. Cardiovascular Devices, Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 22, 1982
Date Received
July 7, 1982
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 Cardiovascular Devices, Inc.

  • K890113 — THE CDI(R) SYSTEM 400 (May 23, 1989)
  • K884228 — CDI(R) 2000 BLOOD GAS MONITOR (January 30, 1989)
  • K871221 — CDI(TM) EXTRACORPOREAL BLOOD GAS SYSTEM 300 (June 5, 1987)
  • K864703 — MODIFIED GAS-STAT(TM) MONITORING SYSTEM (February 19, 1987)
  • K843912 — INTRAVASCULAR BLOOD GAS SYSTEM (January 10, 1985)
  • K840749 — GAST STAT MONITORING SYSTEM (April 17, 1984)
  • K831225 — GAS-STAT MONITORING SYSTEM (May 27, 1983)

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)
  • K900860 — PERFUSION MONITOR (August 14, 1990)
  • K864703 — MODIFIED GAS-STAT(TM) MONITORING SYSTEM (February 19, 1987)
  • K840749 — GAST STAT MONITORING SYSTEM (April 17, 1984)

FDA data resources