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510(k) K182110

CDI Blood Parameter Monitoring System 550 by Terumo Cardiovascular Systems Corporation — Product Code DRY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 2, 2018
Date Received
August 6, 2018
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

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  • K172071 — Terumo Capiox NX19 Oxygenator with Reservoir (east orientation ), Terumo Capiox (March 29, 2018)
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  • K160206 — VirtuoSaph Plus Endoscopic Vessel Harvesting System (April 21, 2016)
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Other clearances for product code DRY

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  • 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)