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510(k) K852309

ERIKA ART LI, 3-9621-8, 22-6, 23-4 & VEN 9714-1 by Erika, Inc. — Product Code FJK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 26, 1985
Date Received
May 29, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Set, Tubing, Blood, With And Without Anti-Regurgitation Valve
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)
  • K850865 — TORAY INDUSTRIES FILTRYZER HOLLOW FIBER KIDNEY B1- (April 3, 1985)
  • K850866 — TORAY INDUSTRIES FILTRYZER HOLLOW FIBER KIDNEY B1L (April 3, 1985)
  • K850654 — TORAY INDUS. FILTRYZER HOLLOW FIBER ARTIFICIAL KID (March 7, 1985)
  • K850655 — TORAY IND. FILTRYZER HOLLOW FIBER ARTIF. KIDNEY B2 (March 7, 1985)
  • K842436 — ERIKA NEGATIVE PRESS. ARTERIAL BLOOD (July 13, 1984)
  • K831174 — FILTRYZER HOLLOW FIBER ARTIFICIAL KID- (June 22, 1984)
  • K831176 — FILTRYZER HOLLOW FIBER ARTIF. KIDNEY (June 22, 1984)
  • K831173 — TORAY INDUSTRIES FILTRYZER HOLLOW FIBER (June 22, 1984)

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  • K213992 — CombiSet Hemodialysis Blood Tubing Set (May 31, 2023)
  • K210782 — Tablo Cartridge (November 26, 2021)
  • K202796 — SANSIN Tubing Sets for Hemodialysis (September 6, 2021)
  • K201866 — NovaLine Tubing Sets for Hemodialysis (March 10, 2021)
  • K171952 — Dimesol Tubing Sets for Hemodialysis (March 30, 2018)
  • K161582 — DORA Tubing Sets for Hemodialysis (June 16, 2017)
  • K150304 — Oxyless Blood Tubing Set (February 24, 2016)