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510(k) K202796

SANSIN Tubing Sets for Hemodialysis by Jiangxi Sanxin Medtec Co., Ltd. — Product Code FJK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 6, 2021
Date Received
September 23, 2020
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 Jiangxi Sanxin Medtec Co., Ltd.

  • K202719 — Disposable Medical Face Masks (January 4, 2021)
  • K142797 — I.V. Catheter (June 18, 2015)

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  • K213992 — CombiSet Hemodialysis Blood Tubing Set (May 31, 2023)
  • K210782 — Tablo Cartridge (November 26, 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)
  • K140841 — TABLO CARTRIDGE (September 11, 2014)