Home / 510(k) Clearances / K890113

510(k) K890113

THE CDI(R) SYSTEM 400 by Cardiovascular Devices, Inc. — Product Code DJY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 23, 1989
Date Received
January 11, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ion-Exchange Chromatography
Device Class
Class I
Regulation Number
862.2230
Review Panel
TX
Submission Type

Other clearances by Cardiovascular Devices, Inc.

  • 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)
  • K822000 — EXTRACORPOREAL BLOOD GAS SYSTEM (December 22, 1982)

Other clearances for product code DJY

  • K883615 — LIQUID CHROMATOGRAPHY COLUMNS 5-7070/71/72/73 (December 16, 1988)
  • K881361 — SOLID PHASE EXTRACTION TUBES (August 8, 1988)
  • K850963 — DUPONT PREP TYPE SI EXTRACITON CARTRIDGE (March 25, 1985)
  • K840985 — TRISACRYL GF 05 & TRISACRYL GF 2000 (April 19, 1984)
  • K832198 — HC40/HC75 PREPACKED COLUMS (August 12, 1983)
  • K831289 — PREFILLED IEC COLUMNS (June 16, 1983)
  • K830693 — DUPONT PREP TYPE AS EXTRACTION CARTRIDE (April 5, 1983)
  • K830692 — DUPONT PREP OD EXTRACTION CARTRIDE (April 5, 1983)
  • K823697 — PREP TYPE A EXTRACTION CARTRIDGE (January 5, 1983)
  • K800061 — BOND ELUT COLUMNS (March 12, 1980)