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510(k) K130851

CASCADE HEMODIALYSIS/APHERESIS CATHETER by Health Line International Corporation — Product Code MSD

Clearance Details

Decision
SESK (Substantially Equivalent (kit))
Decision Date
January 9, 2014
Date Received
March 27, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Hemodialysis, Implanted
Device Class
Class II
Regulation Number
876.5540
Review Panel
GU
Submission Type

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