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510(k) K083675

POWER-TRIALYSIS TRIPLE LUMEN ACUTE DIALYSIS CATHETER by C.R. Bard, Inc. — Product Code NIE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 19, 2009
Date Received
December 11, 2008
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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