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510(k) K962726

Device
Bard Quantum Cvr
Applicant
C.R. BARD, INC.
510(k) number
K962726
Product code
DTP
Decision
Substantially Equivalent (SESE)
Decision date
1996-10-30
Date received
1996-07-15
Regulation
870.4230
Classification name
Defoamer, Cardiopulmonary Bypass
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
DOUGLAS E FERGUSON
Address
25 Computer Dr. Haverhill MA US 01832 01832

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
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K082412VENOUS BUBBLE TRAP, MODEL VBT 160; VENOUS BUBBLE TRAP WITH BIOLINE COATING, MODEL BE-VBT 160, BEQ-VBT 160Mapquet Cardiopulmonary AG2008-11-10
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K002591COBE SMARXT VVR 4000 FILTERED HARDSHELL VENOUS RESERVOIRCobe Cardiovascular, Inc.2000-09-13
K990514MODIFICATION OF BARD QUANTUM CVR, MODEL H-6770VRC.R. Bard, Inc.1999-03-09
K984322DIDECO D920, LILLIPUT 1 TWIN RESERVOIRDideco S.P.A.1999-03-02
K941654SARNS FILTERED VENOUS RESERVIOR MODIFICATION3M Health Care, Sarns1994-07-26
K933496MAXIMA FILTERED HARDSHELL RESERVIORMedtronic Vascular1993-10-15
K912915SARNS NON-FILTERED VENOUS RESERVOIR3M Health Care, Ltd.1991-09-25
K911789MINIMAX (TM) HARDSHELL VENOUS RES W/INTE CARD FILTMedtronic Vascular1991-08-20
K910568MODEL 5866-46 SLEEVE KITMedtronic Vascular1991-04-09
K902437COBE CARDIOTOMY RESERVOIR WITH OR WITHOUT FILTERCobe Laboratories, Inc.1990-12-17
K902856BARD FILTERED CARDIOTOMY RESERVOIRC.R. Bard, Inc.1990-09-27
K902355MCR4000 & MCR4000F CARDIOTOMY RESERVOIRMedtronic Vascular1990-08-23
K874924CAP-35 AND CAP35 FGish Biomedical, Inc.1988-01-19