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510(k) K823068

MEDISYSTEMS FISTULA NEEDLES by Medisystems Corp. — Product Code KOC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 26, 1983
Date Received
October 19, 1982
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 Medisystems Corp.

  • K062953 — MEDISYSTEMS ARTERIAL-VENOUS FISTULA NEEDLE SET WITH SECUREMENT DEVICE (February 12, 2007)
  • K010279 — MEDISYSTEMS LUER ACCESS INJECTION SITE (May 29, 2001)
  • K002372 — ACCESS ALERT GAUGE (October 25, 2000)
  • K994306 — REVERSO (March 20, 2000)
  • K990803 — MEDISYSTEMS BUTTONHOLE NEEDLE SETS (January 6, 2000)
  • K983076 — MEDISYSTEMS TRANSDUCER PROTECTOR (November 25, 1998)
  • K971860 — MEDISYSTEMS DIALYSIS PRIMING SETS (August 18, 1997)
  • K963668 — MEDISYSTEMS PERITONEAL DIALYSIS SETS (August 15, 1997)
  • K970536 — MEDISYSTEMS TRANDUCER PROTECTOR (May 12, 1997)
  • K953823 — ARTERIAL VENOUS BLOOD TUBING SET (September 23, 1996)

Other clearances for product code KOC

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