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510(k) K161582

DORA Tubing Sets for Hemodialysis by Bain Medical Equipment (Guangzhou) Co., Ltd. — Product Code FJK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 16, 2017
Date Received
June 8, 2016
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 Bain Medical Equipment (Guangzhou) Co., Ltd.

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  • K213015 — DORA Disposable A.V. Fistula Needle Sets (April 8, 2022)
  • K201866 — NovaLine Tubing Sets for Hemodialysis (March 10, 2021)
  • K203524 — Surgical Masks (February 25, 2021)
  • K163025 — DORA Disposable A.V. Fistula Needle Sets (July 20, 2017)

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)
  • K150304 — Oxyless Blood Tubing Set (February 24, 2016)
  • K140841 — TABLO CARTRIDGE (September 11, 2014)