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510(k) K900492

Device
Labeling Change - Viaspan(tm) (belzer Uw)
Applicant
THE DU PONT CO.
510(k) number
K900492
Product code
KDL
Decision
Substantially Equivalent (SESE)
Decision date
1990-03-20
Date received
1990-02-02
Regulation
876.5880
Classification name
Set, Perfusion, Kidney, Disposable
Medical specialty
Gastroenterology, Urology
Review panel
Gastroenterology, Urology
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
ANN M GRUMET
Address
Chestnut Run Plz. P.O. Box 80715 Wilmington DE US

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code KDL#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K241239OrganProtex HTK SolutionBridge TO Life, Ltd.2025-01-24
K221386PERF-GEN Pulsatile Perfusion SolutionInstitut Georges Lopez2022-06-14
K221387BEL-GEN Cold Storage SolutionInstitut Georges Lopez2022-06-14
K211842Servator M SALF SolutionS.A.L.F. Spa2021-12-20
K192408Custodiol HTK SolutionDr. Franz Kohler Chemie GmbH2020-04-24
K170150Servator H SALF solution-1000 ml PVC free bags, Servator H SALF solution-2000 ml PVC free bagsS.A.L.F. Spa2017-10-20
K121736PERF-GEN PULSATILE PERFUSION SOLUTIONWaters Medical Systems, LLC2013-08-16
K121618BEL-GEN COLD STORAGE SOLUTIONWaters Medical Systems, LLC2013-06-14
K091656SPS-1TM STATIC PRESERVATION SOLUTION, MODELS SPS-1-500 ML, SPS 1-1L, SPS-1-2LOrgan Recovery Systems, Inc.2010-03-11
K043461CUSTODIOLDr. Franz Kohler Chemie GmbH2005-02-28
K020924CUSTODIOL HTK SOLUTIONDr. Franz Kohler Chemie GmbH2003-01-06
K955497GAMBRO FH 22H FIBER HEMOFLTR/PRISMA FH 22H BLOOD TUBING/HEMOFLTR SETCobe Renal Care, Inc.1997-09-25
K944866VIASPAN (BELZER UW - CSS)The Dupont Merck Pharmaceutical Co.1996-04-22
K891239MOP CATHETERBivona Medical Technologies1989-11-28
K883782BELZER UW-CSSDu Pont Critical Care1989-04-20