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DTQ — Console, Heart-Lung Machine, Cardiopulmonary Bypass Class II

FDA Device Classification

Classification Details

Product Code
DTQ
Device Class
Class II
Regulation Number
870.4220
Submission Type
Review Panel
CV
Medical Specialty
Cardiovascular
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K232291livanova deutschlandEssenz HLM, Essenz ILBMAugust 24, 2023
K221895terumo cardiovascular systems corporationTerumo Advanced Perfusion System 1April 18, 2023
K221373livanova deutschlandEssenz HLMMarch 9, 2023
K210130livanova deutschlandStockert S5 SystemApril 5, 2021
K202125century hlmCentury Perfusion SystemMarch 7, 2021
K190282spectrum medicalQuantum Smart Occluder LH (left-hand), Quantum Smart Occluder LH (right-hand)May 24, 2019
K173834spectrum medicalQuantum Pump ConsoleMay 25, 2018
K172220terumo cardiovascular systems corporationAdvanced Perfusion System 1August 17, 2017
K163531terumo cardiovascular systems corporationAdvanced Perfusion System 1June 7, 2017
K153376terumo cardiovascular systems corporationAdvanced Perfusion System 1December 16, 2015
K151349terumo cardiovascular systems corporationAdvanced Perfusion System 1August 27, 2015
K133598maquet cardiopulmonaryCARDIOHELP SYSTEMMay 21, 2014
K131041terumo cardiovascular systemsADVANCED PERFUSION SYSTEM 1February 20, 2014
K102726maquet cardiopulmonaryCARDIOHELP SYSTEMApril 4, 2011
K103762sorin group deutschlandSORIN C5 SYSTEM; 85/C5 MAST ROLLER PUMP SYSTEM 150(1X RP 150 AND CONTROL PANEL WJanuary 20, 2011
K093882sorin group deutschlandSORIN C5 SYSTEM MODEL 58-00-00January 15, 2010
K092463sorin group deutschlandSORIN B-CARE5 FOR THE STOCKERT S5 SYSTEMNovember 5, 2009
K090006lifebridge medizintechnikLIFEBRIDGE B2T, MODEL 7001October 15, 2009
K091007sorin group deutschlandAIR PURGE CONTROL SYSTEM FOR S5 SYSTEM MODEL 23-45-05July 2, 2009
K080832sorin group deutschlandSTOCKERT S5 SYSTEM, STOCKERT GAS BLENDERJuly 30, 2008