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510(k) K131041

ADVANCED PERFUSION SYSTEM 1 by Terumo Cardiovascular Systems Corp. — Product Code DTQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 20, 2014
Date Received
April 15, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Console, Heart-Lung Machine, Cardiopulmonary Bypass
Device Class
Class II
Regulation Number
870.4220
Review Panel
CV
Submission Type

Other clearances by Terumo Cardiovascular Systems Corp.

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  • K133658 — CDI BLOOD PARAMETER MONITORING SYSTEM 500 (July 25, 2014)
  • K132451 — SARNS SOFT-FLOW AORTIC CANNULA (February 18, 2014)
  • K133151 — SARNS HIGH FLOW AORTIC ARCH CANNULA (February 3, 2014)
  • K130333 — CAPIX RX HOLLOW FIBER OXYGENATOR WITH/WITHOUT HARDSHELL RESERVOIR (March 13, 2013)
  • K130359 — CAPIOX SX18 HOLLOW FIBER OXYGENATOR WITH DETACHABLE HARDSHELL RESERVOIR, CAPIOX (March 13, 2013)
  • K123039 — CDI BLOOD PARAMETER MONITORING SYSTEM 500 (November 20, 2012)
  • 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 DTQ

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  • K221895 — Terumo Advanced Perfusion System 1 (April 18, 2023)
  • K221373 — Essenz HLM (March 9, 2023)
  • K210130 — Stockert S5 System (April 5, 2021)
  • K202125 — Century Perfusion System (March 7, 2021)
  • K190282 — Quantum Smart Occluder LH (left-hand), Quantum Smart Occluder LH (right-hand) (May 24, 2019)
  • K173834 — Quantum Pump Console (May 25, 2018)
  • K172220 — Advanced Perfusion System 1 (August 17, 2017)
  • K163531 — Advanced Perfusion System 1 (June 7, 2017)
  • K153376 — Advanced Perfusion System 1 (December 16, 2015)