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510(k) K123039

CDI BLOOD PARAMETER MONITORING SYSTEM 500 by Terumo Cardiovascular Systems Corp. — Product Code DRY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 20, 2012
Date Received
September 28, 2012
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 Terumo Cardiovascular Systems Corp.

  • K153140 — Terumo Capiox SX18 Oxygenator/ Hardshell Reservoir, Terumo Capiox SX18 Oxygenato (December 2, 2015)
  • K133658 — CDI BLOOD PARAMETER MONITORING SYSTEM 500 (July 25, 2014)
  • K131041 — ADVANCED PERFUSION SYSTEM 1 (February 20, 2014)
  • K132451 — SARNS SOFT-FLOW AORTIC CANNULA (February 18, 2014)
  • K133151 — SARNS HIGH FLOW AORTIC ARCH CANNULA (February 3, 2014)
  • K130359 — CAPIOX SX18 HOLLOW FIBER OXYGENATOR WITH DETACHABLE HARDSHELL RESERVOIR, CAPIOX (March 13, 2013)
  • K130333 — CAPIX RX HOLLOW FIBER OXYGENATOR WITH/WITHOUT HARDSHELL RESERVOIR (March 13, 2013)
  • K113214 — TLINK DATA MANAGEMENT SYSTEM (DMS) (February 7, 2012)
  • K112587 — ADVANCED PERFUSION SYSTEM 1 (APS1) TUBE CLAMP ASSEMBLY, ROLLER PUMP 6 INCH CLASS (December 19, 2011)
  • K112229 — SARN CENTRIFUGAL PUMP (December 9, 2011)

Other clearances for product code DRY

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  • 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)
  • K110957 — M4 MONITOR (May 31, 2011)