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DTP — Defoamer, Cardiopulmonary Bypass Class II

FDA Device Classification

Classification Details

Product Code
DTP
Device Class
Class II
Regulation Number
870.4230
Submission Type
Review Panel
CV
Medical Specialty
Cardiovascular
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K101186medtronic perfusion systemsAFFINITY VARD SUB-ASSEMBLY FOR CPS (CARMEDA COATED), PURGELINE (UNCOATED), HOLDISeptember 3, 2010
K082412mapquet cardiopulmonaryVENOUS BUBBLE TRAP, MODEL VBT 160; VENOUS BUBBLE TRAP WITH BIOLINE COATING, MODENovember 10, 2008
K004046cobe cardiovascularCOBE VVR 4000 FILTERED HARDSHELL VENOUS RESERVOIR, COBE SMARXT VVR 4000 FILTEREDApril 26, 2001
K002591cobe cardiovascularCOBE SMARXT VVR 4000 FILTERED HARDSHELL VENOUS RESERVOIRSeptember 13, 2000
K990514c.r. bardMODIFICATION OF BARD QUANTUM CVR, MODEL H-6770VRMarch 9, 1999
K984322didecoDIDECO D920, LILLIPUT 1 TWIN RESERVOIRMarch 2, 1999
K962726c.r. bardBARD QUANTUM CVROctober 30, 1996
K9416543m health care, sarnsSARNS FILTERED VENOUS RESERVIOR MODIFICATIONJuly 26, 1994
K933496medtronic vascularMAXIMA FILTERED HARDSHELL RESERVIOROctober 15, 1993
K9129153m health careSARNS NON-FILTERED VENOUS RESERVOIRSeptember 25, 1991
K911789medtronic vascularMINIMAX (TM) HARDSHELL VENOUS RES W/INTE CARD FILTAugust 20, 1991
K910568medtronic vascularMODEL 5866-46 SLEEVE KITApril 9, 1991
K902437cobe laboratoriesCOBE CARDIOTOMY RESERVOIR WITH OR WITHOUT FILTERDecember 17, 1990
K902856c.r. bardBARD FILTERED CARDIOTOMY RESERVOIRSeptember 27, 1990
K902355medtronic vascularMCR4000 & MCR4000F CARDIOTOMY RESERVOIRAugust 23, 1990
K874924gish biomedicalCAP-35 AND CAP35 FJanuary 19, 1988
K872167american bentleyCARDIOTOMY/MEDIASTINAL AUTO. RESERVOIR CATR-3500September 1, 1987
K870792gish biomedicalTHORASTAT ATR-XXXXApril 28, 1987
K8607023m health care, sarnsSARNS FILTERED CARDIOTOMY RESERVOIRMay 28, 1986
K860775cardio metricsMEDIASTINAL AUTOTRANSFUSION SYSTEMMay 28, 1986