Home / 510(k) Clearances / K831174

510(k) K831174

FILTRYZER HOLLOW FIBER ARTIFICIAL KID- by Erika, Inc. — Product Code KOC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 22, 1984
Date Received
April 11, 1983
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 Erika, Inc.

  • K853134 — NATIONAL MED CARE INFUSION PUMP ADM SET #95-0001-8 (November 6, 1985)
  • K852310 — NATURALYTE BICARBONATE CONCENTRATE-DRY PACK (July 26, 1985)
  • K852309 — ERIKA ART LI, 3-9621-8, 22-6, 23-4 & VEN 9714-1 (July 26, 1985)
  • K850866 — TORAY INDUSTRIES FILTRYZER HOLLOW FIBER KIDNEY B1L (April 3, 1985)
  • K850865 — TORAY INDUSTRIES FILTRYZER HOLLOW FIBER KIDNEY B1- (April 3, 1985)
  • K850655 — TORAY IND. FILTRYZER HOLLOW FIBER ARTIF. KIDNEY B2 (March 7, 1985)
  • K850654 — TORAY INDUS. FILTRYZER HOLLOW FIBER ARTIFICIAL KID (March 7, 1985)
  • K842436 — ERIKA NEGATIVE PRESS. ARTERIAL BLOOD (July 13, 1984)
  • K831176 — FILTRYZER HOLLOW FIBER ARTIF. KIDNEY (June 22, 1984)
  • K831175 — FILTRYZER HOLLOW FIBER ARTIF. KIDNEY (June 22, 1984)

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)