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510(k) K900306

HEMODIALYSIS BLOOD LINES by Gainor Medical Europe, Ltd. — Product Code KOC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 20, 1990
Date Received
January 21, 1990
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 Gainor Medical Europe, Ltd.

  • K926448 — I.V. ADMINISTRATION SET (May 2, 1994)
  • K931828 — CARELET SAFETY LANCET (October 15, 1993)
  • K931827 — CLEANLET, CLEANLET XL & KIDS (September 13, 1993)
  • K922441 — SURESEAL BANDAGE (August 10, 1993)
  • K913333 — I.V. PRIMING SET (October 23, 1991)
  • K902422 — NEEDLE, ASPIRATION & INJECTION, DISPOSABLE (June 6, 1991)
  • K902420 — CATHETER, NASAL, OXYGEN (April 17, 1991)
  • K902564 — NEEDLE, DIALYSIS (March 1, 1991)
  • K902421 — STOMACH, GASTRO-ENTEROSTOMY (November 20, 1990)
  • K902426 — HEMODIALYSIS SYSTEM AND ACCESSORY (November 20, 1990)

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  • 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)