FDA 510(k)

MedSource TrueSafe安全IV导管，MedSource TrueSafe舒适安全IV导管

K号: K161779 · 2016-11-03

决定日期2016-11-03

产品代码FOZ

咨询委员会医疗设备监管文本翻译如下： HO 请注意，由于您没有提供具体的医疗设备监管文本内容，以上仅为示例。请提供具体的文本内容以便进行准确的翻译。

决定实质等同

器械摘要

MedSource TrueSafe Safety IV Catheter, MedSource TrueSafe Comfort Safety IV Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Medsource International, LLC. It received FDA 510(k) clearance on 2016-11-03 under 510(k) number K161779. The device is classified under product code FOZ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the MedSource TrueSafe Safety IV Catheter, MedSource TrueSafe Comfort Safety IV Catheter?

MedSource TrueSafe Safety IV Catheter, MedSource TrueSafe Comfort Safety IV Catheter is a medical device that received FDA 510(k) clearance on 2016-11-03. The listed applicant is Medsource International, LLC. The 510(k) number is K161779.

When did MedSource TrueSafe Safety IV Catheter, MedSource TrueSafe Comfort Safety IV Catheter receive FDA 510(k) clearance?

MedSource TrueSafe Safety IV Catheter, MedSource TrueSafe Comfort Safety IV Catheter received FDA 510(k) clearance on 2016-11-03, under 510(k) number K161779.

Who is the listed applicant for MedSource TrueSafe Safety IV Catheter, MedSource TrueSafe Comfort Safety IV Catheter?

The FDA 510(k) record lists Medsource International, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MedSource TrueSafe Safety IV Catheter, MedSource TrueSafe Comfort Safety IV Catheter?

The FDA product code for MedSource TrueSafe Safety IV Catheter, MedSource TrueSafe Comfort Safety IV Catheter is FOZ.

列明Medsource International, LLC为申报人的其他记录

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。

K223788MedSource TrueSafe 血液控制 I.V. 安全导管，以及 MedSource ClearSafe 血液控制 I.V. 安全导管

官方来源

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