FDA 510(k) Applications for Medical Device Product Code "DTP"
(Defoamer, Cardiopulmonary Bypass)

FDA 510(k) Number Applicant Device Name Decision Date
K962726 C.R. BARD, INC. BARD QUANTUM CVR 10/30/1996
K990514 C.R. BARD, INC. MODIFICATION OF BARD QUANTUM CVR, MODEL H-6770VR 03/09/1999
K002591 COBE CARDIOVASCULAR, INC. COBE SMARXT VVR 4000 FILTERED HARDSHELL VENOUS RESERVOIR 09/13/2000
K004046 COBE CARDIOVASCULAR, INC. COBE VVR 4000 FILTERED HARDSHELL VENOUS RESERVOIR, COBE SMARXT VVR 4000 FILTERED HARDSHELL VENOUS RESERVOIR 04/26/2001
K984322 DIDECO S.P.A. DIDECO D920, LILLIPUT 1 TWIN RESERVOIR 03/02/1999
K082412 MAPQUET CARDIOPULMONARY AG VENOUS BUBBLE TRAP, MODEL VBT 160; VENOUS BUBBLE TRAP WITH BIOLINE COATING, MODEL BE-VBT 160, BEQ-VBT 160 11/10/2008
K101186 MEDTRONIC PERFUSION SYSTEMS AFFINITY VARD SUB-ASSEMBLY FOR CPS (CARMEDA COATED), PURGELINE (UNCOATED), HOLDING BAG 09/03/2010


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