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510(k) K871221

CDI(TM) EXTRACORPOREAL BLOOD GAS SYSTEM 300 by Cardiovascular Devices, Inc. — Product Code DRY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 5, 1987
Date Received
March 27, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass
Device Class
Class II
Regulation Number
870.4330
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)
  • 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 DRY

  • K234065 — CDI OneView Monitoring System (April 25, 2024)
  • K202154 — B-Capta (April 1, 2021)
  • K202557 — Quantum Workstation 12 Elite (October 2, 2020)
  • K182110 — CDI Blood Parameter Monitoring System 550 (November 2, 2018)
  • K181923 — Quantum Workstation 12.1 (August 17, 2018)
  • K173591 — Quantum Diagnostic Module, Quantum Diagnostic Module - No Gas (March 28, 2018)
  • K163657 — Quantum Workstation (January 18, 2017)
  • K133157 — TRI-OPTIC MEASUREMENT CELL; WITH BALANCE BIOSURFACE, WITH CARMEDA BIOACTIVE SURF (October 23, 2014)
  • K133658 — CDI BLOOD PARAMETER MONITORING SYSTEM 500 (July 25, 2014)
  • K123039 — CDI BLOOD PARAMETER MONITORING SYSTEM 500 (November 20, 2012)