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DWB — Pump, Blood, Cardiopulmonary Bypass, Roller Type Class II

FDA Device Classification

Classification Details

Product Code
DWB
Device Class
Class II
Regulation Number
870.4370
Submission Type
Review Panel
CV
Medical Specialty
Cardiovascular
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K162843terumo cardiovascular systems corporationSmall (4) Roller Pump for the Terumo Advanced Perfusion System 1, Large (6) RollNovember 17, 2016
K131618terumo cardiovascular systems corporationLARGE (6) ROLLER PUMP FOR TERUMO ADVANCED PERFUSION SYSTEM 1; LARGE (6) ROLLER PSeptember 27, 2013
K112587terumo cardiovascular systemsADVANCED PERFUSION SYSTEM 1 (APS1) TUBE CLAMP ASSEMBLY, ROLLER PUMP 6 INCH CLASSDecember 19, 2011
K973237medtronic bio-medicusCSS-CARDIOPLEGIA SAFETY SYSTEMApril 27, 1998
K972321stoeckert instrumenteS3 MAST PUMPFebruary 27, 1998
K971520stoeckert instrumenteS3 CYCLIC RPM CONTROLSeptember 10, 1997
K960974cobe cardiovascularCOBE CENTURY PERFUSION PUMPJuly 14, 1997
K9539013m health care, sarnsSARNS 800 ROLLER PUMPApril 19, 1996
K9539043m health careSARNS 9000 UNIVERSAL ROLLER PUMPApril 19, 1996
K955038stoeckert instrumenteSTOCKERT S3 DOUBLE HEAD PUMP MODULEFebruary 21, 1996
K890904shileyMODIFIED STOCKERT-SHILEY CAPS MULTI. ROLLER PUMPApril 12, 1989
K881780vascucareVASCUCARE ANGIOPUMPSeptember 28, 1988
K874771angiomed u.sANGIOMED INTRODUCING SETSJanuary 12, 1988
K861714shileySTOCKERT-SHILEY MULTIFLOW ROLLER PUMP MODULEJuly 16, 1986
K862116shileySTOCKERT-SHILEY DOUBLE HEAD PUMP MODULEJuly 16, 1986
K831458electromedicsCARDIOPLEGIA RECIRCULATION SYS-BL 705/AOctober 20, 1983
K8207293m health care, sarnsSARNS PULSATILE PUMPNovember 1, 1982
K822071gambroPUMP MODULES PMO LO-110-PMD 10-210August 24, 1982
K813035advocacy internationalPOLYSTAN VERTICLUDE BLOOD PUMPNovember 27, 1981
K802714cobe laboratoriesCOBE/STOCKERT BATTERY MODULENovember 26, 1980