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510(k) K171952

Dimesol Tubing Sets for Hemodialysis by Dimesol, Inc. — Product Code FJK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 30, 2018
Date Received
June 29, 2017
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 Dimesol, Inc.

  • K171505 — Dimesol Disposable AV Fistula Needle Set (Non-Safety Series) and Dimesol Disposa (May 17, 2018)

Other clearances for product code FJK

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  • 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)
  • K161582 — DORA Tubing Sets for Hemodialysis (June 16, 2017)
  • K150304 — Oxyless Blood Tubing Set (February 24, 2016)
  • K140841 — TABLO CARTRIDGE (September 11, 2014)