FDA 510(k) Applications for Medical Device Product Code "DWB"
(Pump, Blood, Cardiopulmonary Bypass, Roller Type)

FDA 510(k) Number Applicant Device Name Decision Date
K953904 3M HEALTH CARE, LTD. SARNS 9000 UNIVERSAL ROLLER PUMP 04/19/1996
K780942 3M HEALTH CARE, SARNS BLOOD PUMP MODEL 7000 06/19/1978
K953901 3M HEALTH CARE, SARNS SARNS 800 ROLLER PUMP 04/19/1996
K820729 3M HEALTH CARE, SARNS SARNS PULSATILE PUMP 11/01/1982
K813035 ADVOCACY INTERNATIONAL, LTD. POLYSTAN VERTICLUDE BLOOD PUMP 11/27/1981
K874771 ANGIOMED U.S., INC. ANGIOMED INTRODUCING SETS 01/12/1988
K960974 COBE CARDIOVASCULAR, INC. COBE CENTURY PERFUSION PUMP 07/14/1997
K802714 COBE LABORATORIES, INC. COBE/STOCKERT BATTERY MODULE 11/26/1980
K831458 ELECTROMEDICS, INC. CARDIOPLEGIA RECIRCULATION SYS-BL 705/A 10/20/1983
K822071 GAMBRO, INC. PUMP MODULES PMO LO-110-PMD 10-210 08/24/1982
K973237 MEDTRONIC BIO-MEDICUS, INC. CSS-CARDIOPLEGIA SAFETY SYSTEM 04/27/1998
K890904 SHILEY, INC. MODIFIED STOCKERT-SHILEY CAPS MULTI. ROLLER PUMP 04/12/1989
K862116 SHILEY, INC. STOCKERT-SHILEY DOUBLE HEAD PUMP MODULE 07/16/1986
K861714 SHILEY, INC. STOCKERT-SHILEY MULTIFLOW ROLLER PUMP MODULE 07/16/1986
K971520 STOECKERT INSTRUMENTE S3 CYCLIC RPM CONTROL 09/10/1997
K972321 STOECKERT INSTRUMENTE S3 MAST PUMP 02/27/1998
K955038 STOECKERT INSTRUMENTE STOCKERT S3 DOUBLE HEAD PUMP MODULE 02/21/1996
K112587 TERUMO CARDIOVASCULAR SYSTEMS CORP. ADVANCED PERFUSION SYSTEM 1 (APS1) TUBE CLAMP ASSEMBLY, ROLLER PUMP 6 INCH CLASSIC COLOR, 12/19/2011
K131618 Terumo Cardiovascular Systems Corporation LARGE (6) ROLLER PUMP FOR TERUMO ADVANCED PERFUSION SYSTEM 1; LARGE (6) ROLLER PUMP FOR TERUMO ADVANCED PERFUSION SYST 09/27/2013
K162843 Terumo Cardiovascular Systems Corporation Small (4) Roller Pump for the Terumo Advanced Perfusion System 1, Large (6) Roller Pump for the Terumo Advanced Perfusion System 1 11/17/2016
K881780 VASCUCARE, INC. VASCUCARE ANGIOPUMP 09/28/1988


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