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510(k) K133456

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

Clearance Details

Decision
SEKD (Substantially Equivalent (kit, denovo))
Decision Date
September 24, 2014
Date Received
November 12, 2013
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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  • K083675 — POWER-TRIALYSIS TRIPLE LUMEN ACUTE DIALYSIS CATHETER (March 19, 2009)
  • K033570 — MEDCOMP T-3 (September 16, 2004)