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Panels › Cardiovascular › Product code DTQ · Class 2

Console, Heart-Lung Machine, Cardiopulmonary Bypass

Regulation 870.4220

0510(k)s in 12 months (52 all time)
1recalls in 12 months (267 all time)
257recalls that name a 510(k)
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Top companies in DTQ

Company510(k)sRecalls
Terumo Cardiovascular Systems Corp.7204
Sorin Group USA, Inc.028
Sorin Group Deutschland GmbH87
Maquet Medical Systems USA010
3M Health Care, Sarns50
Maquet Cardiovascular Us Sales, Llc05
Livanova Deutschland, GmbH31
MAQUET Inc.04
Maquet Cardiopulmonary, AG22
Spectrum Medical , Ltd.22
Decided510(k)Device and applicantCode
Aug 24, 2023K232291Essenz HLM, Essenz ILBM
Livanova Deutschland, GmbH, DE
DTQ
Apr 18, 2023K221895Terumo Advanced Perfusion System 1
Terumo Cardiovascular Systems Corporation
DTQ
Mar 9, 2023K221373Essenz HLM
Livanova Deutschland, GmbH, DE
DTQ
Apr 5, 2021K210130Stockert S5 System
Livanova Deutschland, GmbH, DE
DTQ
Mar 7, 2021K202125Century Perfusion System
Century Hlm, LLC
DTQ
May 24, 2019K190282Quantum Smart Occluder LH (left-hand), Quantum Smart Occluder LH (right-hand)
Spectrum Medical , Ltd., GB
DTQ
May 25, 2018K173834Quantum Pump Console
Spectrum Medical , Ltd., GB
DTQ
Aug 17, 2017K172220Advanced Perfusion System 1
Terumo Cardiovascular Systems Corporation
DTQ
Jun 7, 2017K163531Advanced Perfusion System 1
Terumo Cardiovascular Systems Corporation
DTQ
Dec 16, 2015K153376Advanced Perfusion System 1
Terumo Cardiovascular Systems Corporation
DTQ
Aug 27, 2015K151349Advanced Perfusion System 1
Terumo Cardiovascular Systems Corporation
DTQ
May 21, 2014K133598CARDIOHELP SYSTEM
Maquet Cardiopulmonary, AG
DTQ
Feb 20, 2014K131041ADVANCED PERFUSION SYSTEM 1
Terumo Cardiovascular Systems Corp.
DTQ
Apr 4, 2011K102726CARDIOHELP SYSTEM
Maquet Cardiopulmonary, AG, DE
DTQ
Jan 20, 2011K103762SORIN C5 SYSTEM; 85/C5 MAST ROLLER PUMP SYSTEM 150(1X RP 150 AND CONTROL PANEL WITH CONNECTING CABLES); S5/C5 MAST ROLLE
Sorin Group Deutschland GmbH
DTQ
Jan 15, 2010K093882SORIN C5 SYSTEM MODEL 58-00-00
Sorin Group Deutschland GmbH
DTQ
Nov 5, 2009K092463SORIN B-CARE5 FOR THE STOCKERT S5 SYSTEM
Sorin Group Deutschland GmbH
DTQ
Oct 15, 2009K090006LIFEBRIDGE B2T, MODEL 7001
Lifebridge Medizintechnik AG
DTQ
Jul 2, 2009K091007AIR PURGE CONTROL SYSTEM FOR S5 SYSTEM MODEL 23-45-05
Sorin Group Deutschland GmbH
DTQ
Jul 30, 2008K080832STOCKERT S5 SYSTEM, STOCKERT GAS BLENDER
Sorin Group Deutschland GmbH
DTQ
Jul 6, 2007K071318MODIFICATION TO: STOCKERT S5 SYSTEM
Sorin Group Deutschland GmbH
DTQ
Mar 21, 2007K070213PERFORMER CBP SYSTEM
Rand S.R.L.
DTQ
Sep 28, 2006K062396MODIFICATION TO STOCKERT S5 SYSTEM
Sorin Group Deutschland GmbH
DTQ
Jun 2, 2006K060053STOCKERT S5 SYSTEM
Sorin Group Deutschland GmbH
DTQ
Mar 15, 2006K052555MEDTRONIC PERFORMER TM CPB, MODEL R51, PCPB
Rand S.R.L.
DTQ
Mar 20, 2003K022947ADVANCED PERFUSION SYSTEM 1 (100/120 VOLT),ADVANCED PERFUSION SYSTEM 1 (220/240 VOLT, ROLLER PUMPS (6, 4 INCH
Terumo Cardiovascular Systems Corp.
DTQ
Feb 26, 2003K030141MODIFICATION TO CARDIOVENTION POWERBASE CONSOLE, MODEL PCB-100
Cardiovention, Inc.
DTQ
Jan 8, 2003K021694CARDIOVENTION POWERBASE CONSOLE, MODEL PBC-100
Cardiovention, Inc.
DTQ
Sep 23, 2002K020571STOCKERT CENTRIFUGAL PUMP CONSOLE
Stockert Instrumente GmbH
DTQ
May 2, 2001K011088SIII ALARM AMPLIFIER
Stockert Instrumente GmbH
DTQ
Aug 9, 2000K002118STOCKERT COMPACT SYSTEM VERSION 2.0
Stoeckert Instrumente
DTQ
Aug 9, 2000K002116S3 CARDIOPLEGIA CONTROL MODULE VERSION 2.0
Medical Device Consultants, Inc.
DTQ
Sep 4, 1998K982014STOCKERT COMPACT SYSTEM
Stoeckert Instrumente
DTQ
Aug 5, 1997K964017AFFINITY BLOOD PUMP SYSTEM
Avecor Cardiovascular, Inc.
DTQ
Jan 30, 1996K943803JOSTRA HL-20 INTEGRATED PERFUSION SYSTEM
Janus Biomedical, Inc.
DTQ
Jan 19, 1996K950990STOCKERT S3 ROLLER PUMP MODULE STOCKERT S3 CONSOLE
Stoeckert Instrumente
DTQ
Jan 27, 1995K942582SORIN BLOOD CARDIOPLEGIA CONSOLE
Sorin Biomedical, Inc.
DTQ
Jul 8, 1992K915183SARNS 8000 MODULAR PERFUSION SYSTEM
3M Health Care, Sarns
DTQ
May 21, 1987K871131SARNS 9000 HEART-LUNG CONSOLE
3M Health Care, Sarns
DTQ
May 6, 1987K870976ONGUARD 1000, CATALOG #043611-000 & 043611-001
Cobe Laboratories, Inc.
DTQ
Dec 11, 1986K863960STOCKERT-SHILEY CAPS BATTERY MODULE
Shiley, Inc.
DTQ
Nov 18, 1986K863541STOCKERT-SHILEY CAPS HLM INTERFACE
Shiley, Inc.
DTQ
Oct 1, 1986K862973STOCKERT-SHILEY CAPS TIMER MODULE
Shiley, Inc.
DTQ
Jun 23, 1986K861388SARNS PORTABLE POWER MODULE
3M Health Care, Sarns
DTQ
Jun 19, 1985K851615CENTRIMED SYSTEM 1 W/MANUAL PUMP DRIVE
Centrimed Corp.
DTQ
Jun 19, 1985K851614CENTRIMED SYSTEM 1 W/24 VOLT BATTERY POWER SUPPLY
Centrimed Corp.
DTQ
Aug 3, 1984K842138COBE EMERGENCY POWER SOURCE 43610-000
Cobe Laboratories, Inc.
DTQ
Aug 24, 1982K822068GAMBRO PUMP CONSOLE CSL
Gambro, Inc.
DTQ
Nov 27, 1981K813034POLYSTAN HEART LUNG MACHINE SYS
Advocacy International, Ltd.
DTQ
May 20, 1980K801097SARNS 7000 MONITOR MODULE
3M Health Care, Sarns
DTQ

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