FDA 510(k) Applications for Medical Device Product Code "DWA"
(Control, Pump Speed, Cardiopulmonary Bypass)

FDA 510(k) Number Applicant Device Name Decision Date
K950739 3M HEALTH CARE, SARNS 3M SARNS FLOW SENSOR, CENTRIFUGAL CONTROL MODULE 115, 220 V, 900 PERFUSION SYSTEM 11/17/1995
K854133 BIO MEDICUS, INC. BIO MEDICUS BIO CONSOLE 540 01/08/1986
K901584 BIO MEDICUS, INC. BIO-MEDICUS BIO CONSOLE MODELS 540 A B C 06/28/1990
K971421 C.R. BARD, INC. BARD ISOFLOW BLOOD PUMP 05/14/1998
K061369 CARDIAC ASSIST, INC. TANDEM HEART ESCORT (T.H.E.) CONTROLLER, MODEL 5140-8500 08/22/2006
K842503 GAMBRO, INC. GAMBRO PULSATILE MONITOR PLM 10-200 08/10/1984
K102129 LEVITRONIX LLC. LEVITRONIX 2ND GENERATION CENTRIMAG PRIMARY CONSOLE, LEVITRONIX MONITOR 08/27/2010
K093832 LEVITRONIX LLC. LEVITRONIX CENTRIMAG PRIMARY AND BACKUP CONSOLES 01/13/2010
K053630 LEVITRONIX LLC. LEVITRONIX CENTRIMAG PRIMARY CONSOLE 01/26/2006
K081221 LEVITRONIX LLC. LEVITRONIX CENTRIMAG PRIMARY CONSOLE, THORATEC CENTRIMAG PRIMARY CONSOLE 06/19/2008
K083340 LEVITRONIX LLC. LEVITRONIX CENTRIMAG PRIMARY CONSOLE; THORATEC CANTRIMAG PRIMARY CONSOLE 11/26/2008
K090004 LEVITRONIX LLC. LEVITRONIX, THORATEC CENTRIMAG BACK-UP CONSOLES 01/15/2009
K070286 Medtronic BIO-CONSOLE, MODEL 560 05/22/2007
K941921 MEDTRONIC BIO-MEDICUS, INC. BIO-MEDICUS BIO-CONSOLE MODELS 540, 540A,B,C,D,E, & 550 07/20/1994
K914754 MEDTRONIC BIO-MEDICUS, INC. MEDTRONIC BIO-MEDICUS BIO-CONSOLE MODEL 540-D 05/20/1992
K924206 MEDTRONIC BIO-MEDICUS, INC. MEDTRONIC BIO-MEDICUS BIO-CONSOLE MODEL 540E 05/07/1993
K924205 MEDTRONIC BIO-MEDICUS, INC. MEDTRONIC BIO-MEDICUS BIO-CONSOLE MODEL 550 05/06/1993
K936091 MEDTRONIC BIO-MEDICUS, INC. MEDTRONIC BIO-MEDICUS BIO-CONSOLE MODEL 550M PUMP SPEED CONTROLLER 12/23/1994
K926357 MEDTRONIC BIO-MEDICUS, INC. MEDTRONIC BIO-MEDICUS HANDCRANK MODEL 150 06/02/1993
K131964 MEDTRONIC INC. BIO-CONSOLE 560 EXTRACORPOREAL BLOOD PUMPING CONSOLE 07/24/2013
K080824 MEDTRONIC PERFUSION SYSTEMS BIO-CONSOLE 560 05/07/2008
K051303 MEDTRONIC PERFUSION SYSTEMS BIO-CONSOLE, MODEL 560 06/10/2005
K780952 MEDTRONIC VASCULAR MODEL 1812 CONTROL CONSOLE, ACCESSORIEX 08/31/1978
K112225 SORIN GROUP DEUTSCHLAND GMBH SORIN CENTRIFUGAL PUMP 5 (CP5) 09/20/2011
K103468 SORIN GROUP DEUTSCHLAND GMBH STOCKERT CENTRIFUGAL PUMP (SCP PLUS) (COMPLETE) OR (FOR S5/C5 SYSTEMS) 01/20/2011
K091008 SORIN GROUP DEUTSCHLAND GMBH STOCKERT CENTRIFUGAL PUMP PLUS SYSTEM (SCP PLUS), MODELS 60-00-10, 60-00-55 07/15/2009
K011838 STOCKERT INSTRUMENTE GMBH CENTRIFUGAL PUMP 02/05/2002
K032213 STOCKERT INSTRUMENTE GMBH STOCKERT CENTRIFUGAL PUMP SYSTEM WITH TUBING CLAMP 08/29/2003
K042374 STOCKERT INSTRUMENTE GMBH STOCKERT SCP RHYTHM 09/23/2004
K131179 THORATEC CORP CENTRIMAG PRIMARY CONSOLE (2ND GENERATION); MAG MONITOR 07/18/2013


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