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510(k) K160444

FB-U Hemodialyzer by Nipro Medical Corporation — Product Code KDI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 8, 2017
Date Received
February 17, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dialyzer, High Permeability With Or Without Sealed Dialysate System
Device Class
Class II
Regulation Number
876.5860
Review Panel
GU
Submission Type

Other clearances by Nipro Medical Corporation

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  • K191359 — Nipro Syringe (October 9, 2019)
  • K182940 — Surdial DX Hemodialysis System (July 19, 2019)
  • K173029 — Nipro Syringe (March 30, 2018)
  • K161681 — Nipro SafeTouch IV Catheter (March 8, 2017)
  • K151141 — Cronus HP - High Pressure Peripheral Balloon Catheter (January 14, 2016)
  • K140191 — ELISIO-H HEMODIALYZER (April 14, 2014)
  • K140136 — NIPRO SAFETOUCH PSV SCALP VEIN SET WITH SAFETY DEVICE (February 14, 2014)

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