VITAL Tubing Sets for Hemodialysis
K-Number: K251341 · 2026-01-16
ApplicantVital Healthcare Sdn. Bhd.
Decision Date2026-01-16
Product CodeFJK
Advisory CommitteeGU
DecisionSubstantially Equivalent
Device Summary
VITAL Tubing Sets for Hemodialysis is a medical device manufactured by Vital Healthcare Sdn. Bhd.. It received FDA 510(k) clearance on 2026-01-16 under approval number K251341. The device is classified under product code FJK. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the VITAL Tubing Sets for Hemodialysis?
VITAL Tubing Sets for Hemodialysis is a medical device that received FDA 510(k) clearance on 2026-01-16. It is manufactured by Vital Healthcare Sdn. Bhd.. The 510(k) number is K251341.
When was VITAL Tubing Sets for Hemodialysis approved by the FDA?
VITAL Tubing Sets for Hemodialysis received FDA 510(k) clearance on 2026-01-16, under approval number K251341.
What company makes VITAL Tubing Sets for Hemodialysis?
VITAL Tubing Sets for Hemodialysis is manufactured by Vital Healthcare Sdn. Bhd..
What is the FDA product code for VITAL Tubing Sets for Hemodialysis?
The FDA product code for VITAL Tubing Sets for Hemodialysis is FJK.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.