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510(k) K832811

Device
Shiley 3l Cardf Plus
Applicant
SHILEY, INC.
510(k) number
K832811
Product code
DTP
Decision
Substantially Equivalent (SESE)
Decision date
1983-09-20
Date received
1983-08-18
Regulation
870.4230
Classification name
Defoamer, Cardiopulmonary Bypass
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
4221 Richmond Rd., NW Walker MI US 49534 49534

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

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510(k), Device, Applicant table
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K984322DIDECO D920, LILLIPUT 1 TWIN RESERVOIRDideco S.P.A.1999-03-02
K962726BARD QUANTUM CVRC.R. Bard, Inc.1996-10-30
K941654SARNS FILTERED VENOUS RESERVIOR MODIFICATION3M Health Care, Sarns1994-07-26
K933496MAXIMA FILTERED HARDSHELL RESERVIORMedtronic Vascular1993-10-15
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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