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510(k) K944866

VIASPAN (BELZER UW - CSS) by The Dupont Merck Pharmaceutical Co. — Product Code KDL

K944866 is an FDA 510(k) premarket notification submitted by The Dupont Merck Pharmaceutical Co. for the device "VIASPAN (BELZER UW - CSS)". The FDA issued a decision of Substantially Equivalent on April 22, 1996. The device falls under product code KDL (Set, Perfusion, Kidney, Disposable), a Class II device regulated under 21 CFR 876.5880.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 22, 1996
Date Received
October 3, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Set, Perfusion, Kidney, Disposable
Device Class
Class II
Regulation Number
876.5880
Review Panel
GU
Submission Type

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  • K091656 — SPS-1TM STATIC PRESERVATION SOLUTION, MODELS SPS-1-500 ML, SPS 1-1L, SPS-1-2L (March 11, 2010)
  • K043461 — CUSTODIOL (February 28, 2005)

FDA data resources