VITAL 血液透析管路套装
K号: K251341 · 2026-01-16
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决定日期2026-01-16
产品代码FJK
咨询委员会GU
请注意，由于您只提供了“GU”这个词，我无法提供完整的翻译。如果您能提供完整的句子或段落，我将能够为您提供准确的翻译。
决定实质等同
器械摘要
VITAL Tubing Sets for Hemodialysis is the device name listed in this FDA 510(k) record. The listed applicant is Vital Healthcare Sdn. Bhd.. It received FDA 510(k) clearance on 2026-01-16 under 510(k) number K251341. The device is classified under product code FJK. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
常见问题
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. The listed applicant is Vital Healthcare Sdn. Bhd.. The 510(k) number is K251341.
When did VITAL Tubing Sets for Hemodialysis receive FDA 510(k) clearance?
VITAL Tubing Sets for Hemodialysis received FDA 510(k) clearance on 2026-01-16, under 510(k) number K251341.
Who is the listed applicant for VITAL Tubing Sets for Hemodialysis?
The FDA 510(k) record lists Vital Healthcare Sdn. Bhd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for VITAL Tubing Sets for Hemodialysis?
The FDA product code for VITAL Tubing Sets for Hemodialysis is FJK.
相关临床试验
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相关器械（代码：FJK）
关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。
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官方来源
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