Home / 510(k) Clearances / K022536

510(k) K022536

\RESENIUS ACCESS FLOW RESERVING CONNECTORS, FRESENIUS STANDALONE ACCCES FLOW RESERVING CONNECTOR by Fresenius Medical Care — Product Code KOC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 30, 2002
Date Received
August 1, 2002
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

Other clearances by Fresenius Medical Care

  • K231534 — 5008X Hemodialysis System (February 2, 2024)
  • K141997 — CRIT-LINE IV SYSTEM (April 1, 2015)
  • K111639 — FRESENIUS 2008T HEMODIALYSIS MACHINE (October 21, 2011)
  • K030497 — FRESENIUS NATURALYTE GRANUFLO DRY ACID CONCENTRATE 10XX SERIES, 24XX SERIES, 30X (May 20, 2003)
  • K023162 — FRESENIUS PUNCTUR-GUARD FISTULA NEEDLE SETS (March 20, 2003)
  • K994267 — FRESENIUS 2008K (March 16, 2000)

Other clearances for product code KOC

  • K242479 — BLOOD TUBING LINES FOR HEMODIALYSIS AL Series (Archloop) BLOOD TUBING LINES FOR (May 15, 2025)
  • K242176 — 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)
  • K141997 — CRIT-LINE IV SYSTEM (April 1, 2015)
  • K141281 — CRIT-LINE CLIP (CLIC) BLOOD CHAMBER (August 14, 2014)