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510(k) K161504

Cook Turbo-Flo HD Acute Hemodialysis Catheter Set/Tray by Cook Incorporated — Product Code MPB

Clearance Details

Decision
SEKD (Substantially Equivalent (kit, denovo))
Decision Date
January 6, 2017
Date Received
June 1, 2016
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

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

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  • K110793 — AMECATH AND AMECATH UNIQATH SOFT SHORT TERM DUAL HEMODIALYSIS CATHETERIZATION KI (December 16, 2011)
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