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510(k) K103551

INTERLINK S / CLEARLINK SYSTEM / V-LINK LAD WITH VITALSHIELD PROTECTIVE COATING NON-DEHP CATHETER EXTENSION SET KITS, by Baxter Healthcare Corp — Product Code FPA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 25, 2011
Date Received
December 2, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Set, Administration, Intravascular
Device Class
Class II
Regulation Number
880.5440
Review Panel
HO
Submission Type

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