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510(k) K163531

Advanced Perfusion System 1 by Terumo Cardiovascular Systems Corporation — Product Code DTQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 7, 2017
Date Received
December 16, 2016
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 Corporation

  • K234065 — CDI OneView Monitoring System (April 25, 2024)
  • 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)
  • 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 DTQ

  • K232291 — Essenz HLM, Essenz ILBM (August 24, 2023)
  • 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)
  • K153376 — Advanced Perfusion System 1 (December 16, 2015)
  • K151349 — Advanced Perfusion System 1 (August 27, 2015)