FDA 510(k) Applications for Medical Device Product Code "DTQ"
(Console, Heart-Lung Machine, Cardiopulmonary Bypass)

FDA 510(k) Number Applicant Device Name Decision Date
K772001 3M HEALTH CARE, SARNS SARNES HELP 11/02/1977
K801097 3M HEALTH CARE, SARNS SARNS 7000 MONITOR MODULE 05/20/1980
K915183 3M HEALTH CARE, SARNS SARNS 8000 MODULAR PERFUSION SYSTEM 07/08/1992
K871131 3M HEALTH CARE, SARNS SARNS 9000 HEART-LUNG CONSOLE 05/21/1987
K861388 3M HEALTH CARE, SARNS SARNS PORTABLE POWER MODULE 06/23/1986
K813034 ADVOCACY INTERNATIONAL, LTD. POLYSTAN HEART LUNG MACHINE SYS 11/27/1981
K964017 AVECOR CARDIOVASCULAR, INC. AFFINITY BLOOD PUMP SYSTEM 08/05/1997
K021694 CARDIOVENTION, INC. CARDIOVENTION POWERBASE CONSOLE, MODEL PBC-100 01/08/2003
K030141 CARDIOVENTION, INC. MODIFICATION TO CARDIOVENTION POWERBASE CONSOLE, MODEL PCB-100 02/26/2003
K851614 CENTRIMED CORP. CENTRIMED SYSTEM 1 W/24 VOLT BATTERY POWER SUPPLY 06/19/1985
K851615 CENTRIMED CORP. CENTRIMED SYSTEM 1 W/MANUAL PUMP DRIVE 06/19/1985
K842138 COBE LABORATORIES, INC. COBE EMERGENCY POWER SOURCE 43610-000 08/03/1984
K770002 COBE LABORATORIES, INC. CONSOLE, MOBILE FOR 3 PUMPS W/MASTS 03/07/1977
K870976 COBE LABORATORIES, INC. ONGUARD 1000, CATALOG #043611-000 & 043611-001 05/06/1987
K822068 GAMBRO, INC. GAMBRO PUMP CONSOLE CSL 08/24/1982
K943803 JANUS BIOMEDICAL, INC. JOSTRA HL-20 INTEGRATED PERFUSION SYSTEM 01/30/1996
K090006 LIFEBRIDGE MEDIZINTECHNIK AG LIFEBRIDGE B2T, MODEL 7001 10/15/2009
K133598 MAQUET CARDIOPULMONARY AG CARDIOHELP SYSTEM 05/21/2014
K102726 MAQUET CARDIOPULMONARY AG CARDIOHELP SYSTEM 04/04/2011
K002116 MEDICAL DEVICE CONSULTANTS, INC. S3 CARDIOPLEGIA CONTROL MODULE VERSION 2.0 08/09/2000
K052555 RAND S.R.L. MEDTRONIC PERFORMER TM CPB, MODEL R51, PCPB 03/15/2006
K070213 RAND S.R.L. PERFORMER CBP SYSTEM 03/21/2007
K863960 SHILEY, INC. STOCKERT-SHILEY CAPS BATTERY MODULE 12/11/1986
K863541 SHILEY, INC. STOCKERT-SHILEY CAPS HLM INTERFACE 11/18/1986
K862973 SHILEY, INC. STOCKERT-SHILEY CAPS TIMER MODULE 10/01/1986
K942582 SORIN BIOMEDICAL, INC. SORIN BLOOD CARDIOPLEGIA CONSOLE 01/27/1995
K091007 SORIN GROUP DEUTSCHLAND GMBH AIR PURGE CONTROL SYSTEM FOR S5 SYSTEM MODEL 23-45-05 07/02/2009
K062396 SORIN GROUP DEUTSCHLAND GMBH MODIFICATION TO STOCKERT S5 SYSTEM 09/28/2006
K071318 SORIN GROUP DEUTSCHLAND GMBH MODIFICATION TO: STOCKERT S5 SYSTEM 07/06/2007
K092463 SORIN GROUP DEUTSCHLAND GMBH SORIN B-CARE5 FOR THE STOCKERT S5 SYSTEM 11/05/2009
K093882 SORIN GROUP DEUTSCHLAND GMBH SORIN C5 SYSTEM MODEL 58-00-00 01/15/2010
K103762 SORIN GROUP DEUTSCHLAND GMBH SORIN C5 SYSTEM; 85/C5 MAST ROLLER PUMP SYSTEM 150(1X RP 150 AND CONTROL PANEL WITH CONNECTING CABLES); S5/C5 MAST ROLLE 01/20/2011
K060053 SORIN GROUP DEUTSCHLAND GMBH STOCKERT S5 SYSTEM 06/02/2006
K080832 SORIN GROUP DEUTSCHLAND GMBH STOCKERT S5 SYSTEM, STOCKERT GAS BLENDER 07/30/2008
K173834 Spectrum Medical Ltd Quantum Pump Console 05/25/2018
K011088 STOCKERT INSTRUMENTE GMBH SIII ALARM AMPLIFIER 05/02/2001
K020571 STOCKERT INSTRUMENTE GMBH STOCKERT CENTRIFUGAL PUMP CONSOLE 09/23/2002
K982014 STOECKERT INSTRUMENTE STOCKERT COMPACT SYSTEM 09/04/1998
K002118 STOECKERT INSTRUMENTE STOCKERT COMPACT SYSTEM VERSION 2.0 08/09/2000
K950990 STOECKERT INSTRUMENTE STOCKERT S3 ROLLER PUMP MODULE STOCKERT S3 CONSOLE 01/19/1996
K131041 TERUMO CARDIOVASCULAR SYSTEMS CORP. ADVANCED PERFUSION SYSTEM 1 02/20/2014
K022947 TERUMO CARDIOVASCULAR SYSTEMS CORP. ADVANCED PERFUSION SYSTEM 1 (100/120 VOLT),ADVANCED PERFUSION SYSTEM 1 (220/240 VOLT, ROLLER PUMPS (6, 4 INCH 03/20/2003
K151349 Terumo Cardiovascular Systems Corporation Advanced Perfusion System 1 08/27/2015
K153376 Terumo Cardiovascular Systems Corporation Advanced Perfusion System 1 12/16/2015
K163531 TERUMO CARDIOVASCULAR SYSTEMS CORPORATION Advanced Perfusion System 1 06/07/2017
K172220 Terumo Cardiovascular Systems Corporation Advanced Perfusion System 1 08/17/2017


Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact