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510(k) K151967

Centros Long-Term Hemodialysis Catheter, CentrosFLO Long-Term Hemodialysis Catheter by Merit Medical Systems, Inc. — Product Code MSD

Clearance Details

Decision
SESK (Substantially Equivalent (kit))
Decision Date
April 4, 2016
Date Received
July 16, 2015
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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  • K182443 — Pristine Hemodialysis Catheter (May 31, 2019)