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510(k) K163458

Zenysis Short-Term Dialysis Catheter by C.R. Bard, Inc. — Product Code MPB

Clearance Details

Decision
SEKD (Substantially Equivalent (kit, denovo))
Decision Date
April 4, 2017
Date Received
December 9, 2016
Clearance Type
Traditional
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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Other clearances for product code MPB

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  • K161504 — Cook Turbo-Flo HD Acute Hemodialysis Catheter Set/Tray (January 6, 2017)
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  • K122091 — COOK TURBO-FLO HD ACUTE HEMODIALYSIS CATHETER SET/TRAY COOK SPECTRUM TURBO-FLO H (July 29, 2013)
  • K120674 — MAHURKAR ELITE ACUTE DUAL LUMEN CATHETER, ELITE ACUTE TRIPLE LUMEN CATHETER (April 4, 2012)
  • K110793 — AMECATH AND AMECATH UNIQATH SOFT SHORT TERM DUAL HEMODIALYSIS CATHETERIZATION KI (December 16, 2011)
  • K102833 — DISPOSABLE HEMODIALYSIS ACCESS CATHETER SETS (November 18, 2011)