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510(k) K141531

POWER-TRIALYSIS SLIM-CATH SHORT-TERM DIALYSIS CATHETER by C.R. Bard, Inc. — Product Code NIE

Clearance Details

Decision
SEKD (Substantially Equivalent (kit, denovo))
Decision Date
June 1, 2015
Date Received
June 9, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

Short-term (< 30 days) central venous access for hemodialysis and apheresis, with a third lumen for infusion.

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