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510(k) K853851

FRESENIUS DISPOSABLE BLOOD LINES by Seratronics, Inc. — Product Code FJK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 12, 1985
Date Received
September 16, 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 Seratronics, Inc.

  • K955299 — DPS 4 DIALYZER PREPARATION SYSTEM (October 21, 1996)
  • K931336 — DRS 4 DIALYZER REPROCESSING SYSTEM (April 18, 1996)
  • K944539 — DRS 4 ND DIALYZER REPROCESSING SYSTEM (November 29, 1995)
  • K923529 — DMS DATA MANAGEMENT SYSTEM/DRS-4 DIALYZER REPROCES (August 29, 1994)
  • K914580 — DRS-4 DIALYZER REPROCESSING SYSTEM (February 24, 1992)
  • K874573 — FRESENIUS PURISTERIL 340 (TM) (April 25, 1988)
  • K874872 — FRESENIUS HEMOFLOW F3, F4, F5, F7 (February 19, 1988)
  • K870725 — FRESENIUS HEMOFLOW F6 AND F8 (May 1, 1987)
  • K870724 — FRESENIUS HEMOFLOW F60 AND F80 (April 1, 1987)
  • K864587 — FRESENIUS ULTRAFLUX AV400, AV600 (March 3, 1987)

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)