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510(k) K141997

CRIT-LINE IV SYSTEM by Fresenius Medical Care — Product Code KOC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 1, 2015
Date Received
July 23, 2014
Clearance Type
Traditional
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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  • K023162 — FRESENIUS PUNCTUR-GUARD FISTULA NEEDLE SETS (March 20, 2003)
  • K022536 — \RESENIUS ACCESS FLOW RESERVING CONNECTORS, FRESENIUS STANDALONE ACCCES FLOW RES (October 30, 2002)
  • K994267 — FRESENIUS 2008K (March 16, 2000)

Other clearances for product code KOC

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  • K242479 — BLOOD TUBING LINES FOR HEMODIALYSIS AL Series (Archloop) BLOOD TUBING LINES FOR (May 15, 2025)
  • 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)
  • K201207 — CombiSet SMARTECH Hemodialysis Blood Tubing Set with attached Priming Set and In (September 18, 2020)
  • K172238 — CAREline Airless Hemodialysis Blood Tubing Sets (December 14, 2017)
  • K160749 — CRIT-LINE III Blood Chamber II (April 15, 2016)
  • K152953 — CRIT-LINE CLIP (CLIC) BLOOD CHAMBER (November 5, 2015)
  • K141281 — CRIT-LINE CLIP (CLIC) BLOOD CHAMBER (August 14, 2014)
  • K121599 — CRIT-LINE CLIP (CLIC) (November 9, 2012)