Home / 510(k) Clearances / K234065

510(k) K234065

CDI OneView Monitoring System by Terumo Cardiovascular Systems Corporation — Product Code DRY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 25, 2024
Date Received
December 22, 2023
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 Corporation

  • K221895 — Terumo Advanced Perfusion System 1 (April 18, 2023)
  • K200091 — Capiox iCP Centrifugal Pump (November 18, 2021)
  • K182110 — CDI Blood Parameter Monitoring System 550 (November 2, 2018)
  • K180950 — Terumo Capiox NX19 Oxygenator with Reservoir (east Orientation), Terumo Capiox N (June 22, 2018)
  • K172071 — Terumo Capiox NX19 Oxygenator with Reservoir (east orientation ), Terumo Capiox (March 29, 2018)
  • K172220 — Advanced Perfusion System 1 (August 17, 2017)
  • K163531 — Advanced Perfusion System 1 (June 7, 2017)
  • K162843 — Small (4) Roller Pump for the Terumo Advanced Perfusion System 1, Large (6) Roll (November 17, 2016)
  • K160206 — VirtuoSaph Plus Endoscopic Vessel Harvesting System (April 21, 2016)
  • K153376 — Advanced Perfusion System 1 (December 16, 2015)

Other clearances for product code DRY

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