FDA.reportPublic FDA data

510(k) K221373

Device
Essenz HLM
Applicant
Livanova Deutschland, GmbH
510(k) number
K221373
Product code
DTQ
Decision
Substantially Equivalent (SESE)
Decision date
2023-03-09
Date received
2022-05-12
Regulation
870.4220
Classification name
Console, Heart-Lung Machine, Cardiopulmonary Bypass
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Julia E. Leslie
Address
Lindberghstr. 25 Munich DE 80939 80939

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code DTQ#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K232291Essenz HLM, Essenz ILBMLivanova Deutschland, GmbH2023-08-24
K221895Terumo Advanced Perfusion System 1Terumo Cardiovascular Systems Corporation2023-04-18
K210130Stockert S5 SystemLivanova Deutschland, GmbH2021-04-05
K202125Century Perfusion SystemCentury Hlm, LLC2021-03-07
K190282Quantum Smart Occluder LH (left-hand), Quantum Smart Occluder LH (right-hand)Spectrum Medical , Ltd.2019-05-24
K173834Quantum Pump ConsoleSpectrum Medical , Ltd.2018-05-25
K172220Advanced Perfusion System 1Terumo Cardiovascular Systems Corporation2017-08-17
K163531Advanced Perfusion System 1Terumo Cardiovascular Systems Corporation2017-06-07
K153376Advanced Perfusion System 1Terumo Cardiovascular Systems Corporation2015-12-16
K151349Advanced Perfusion System 1Terumo Cardiovascular Systems Corporation2015-08-27
K133598CARDIOHELP SYSTEMMaquet Cardiopulmonary, AG2014-05-21
K131041ADVANCED PERFUSION SYSTEM 1Terumo Cardiovascular Systems Corp.2014-02-20
K102726CARDIOHELP SYSTEMMaquet Cardiopulmonary, AG2011-04-04
K103762SORIN C5 SYSTEM; 85/C5 MAST ROLLER PUMP SYSTEM 150(1X RP 150 AND CONTROL PANEL WITH CONNECTING CABLES); S5/C5 MAST ROLLESorin Group Deutschland GmbH2011-01-20
K093882SORIN C5 SYSTEM MODEL 58-00-00Sorin Group Deutschland GmbH2010-01-15