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510(k) K251341

VITAL Tubing Sets for Hemodialysis by Vital Healthcare Sdn. Bhd. — Product Code FJK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 16, 2026
Date Received
April 30, 2025
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

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