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510(k) K160749

CRIT-LINE III Blood Chamber II by Fresenius Medical Care Renal Therapies Group, LLC — Product Code KOC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 15, 2016
Date Received
March 18, 2016
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Accessories, Blood Circuit, Hemodialysis
Device Class
Class II
Regulation Number
876.5820
Review Panel
GU
Submission Type

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  • K231589 — Blood Tubing Lines for Hemodialysis AV06C-E (July 28, 2023)
  • K230514 — Blood Tubing Lines for Hemodialysis AL Series (Archloop), Blood Tubing Lines for (June 16, 2023)
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  • K172238 — CAREline Airless Hemodialysis Blood Tubing Sets (December 14, 2017)
  • K152953 — CRIT-LINE CLIP (CLIC) BLOOD CHAMBER (November 5, 2015)
  • K141997 — CRIT-LINE IV SYSTEM (April 1, 2015)
  • K141281 — CRIT-LINE CLIP (CLIC) BLOOD CHAMBER (August 14, 2014)
  • K121599 — CRIT-LINE CLIP (CLIC) (November 9, 2012)