Home / 510(k) Clearances / K771693

510(k) K771693

CLIRANS BLOOD LINES SET by Terumo America, Inc. — Product Code FJK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 20, 1977
Date Received
September 6, 1977
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 Terumo America, Inc.

  • K811523 — PLASMA FLEX (September 9, 1981)
  • K802970 — TERUMO HOLLOW FIBER OXYGENATOR (January 22, 1981)
  • K802122 — CLIRANS TH13 HOLLOW FIBER DIALYZER (December 18, 1980)
  • K802441 — CLIRANS TH10 HOLLOW FIBER DIALYZER (December 18, 1980)
  • K801194 — CLIRANS TE07 HOLLOW FIBER DIALYZER (August 12, 1980)
  • K801193 — CLIRANS TE15 HOLLOW FIBER DIALYZER (August 12, 1980)
  • K801192 — CLIRANS TE10 HOLLOW FIBER DIALYZER (August 12, 1980)
  • K791411 — COAXIAL DUAL FLOW CATHETER (November 13, 1979)
  • K791173 — SURFLO INJECTION PLUG (July 30, 1979)
  • K790105 — TERUMO IMUGARD (May 24, 1979)

Other clearances for product code FJK

  • K251341 — VITAL Tubing Sets for Hemodialysis (January 16, 2026)
  • K251442 — TIANYI Extracorporeal Blood Tubing Set (TY-NDEO-A1) (October 2, 2025)
  • K243607 — Moda-flx Hemodialysis System™ Cartridge (102121-001 ) (December 20, 2024)
  • 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)