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510(k) K173718

Liberty Cycler Set by Fresenius Medical Care Renal Therapies Group, LLC — Product Code FKX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 1, 2018
Date Received
December 5, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Peritoneal, Automatic Delivery
Device Class
Class II
Regulation Number
876.5630
Review Panel
GU
Submission Type

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Other clearances for product code FKX

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  • K212522 — Lilliput APD System (April 15, 2022)
  • K212658 — CloudCath Peritoneal Dialysis Drain Set Monitoring System (February 9, 2022)
  • K201867 — Homechoice Claria APD System, Sharesource Connectivity Platform for Use with the (November 19, 2020)
  • K181108 — Fresenius Liberty Select Cycler (May 24, 2018)
  • K171652 — Fresenius Liberty Select Cycler (September 15, 2017)
  • K151525 — Amia Automated PD System with Sharesource (October 9, 2015)