FDA 510(k)

QuikClot Control+ 止血装置

K号: K243553 · 2025-03-18

决定日期2025-03-18

产品代码POD

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决定实质等同

器械摘要

QuikClot Control+ Hemostatic Device is the device name listed in this FDA 510(k) record. The listed applicant is Teleflex Medical. It received FDA 510(k) clearance on 2025-03-18 under 510(k) number K243553. The device is classified under product code POD. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the QuikClot Control+ Hemostatic Device?

QuikClot Control+ Hemostatic Device is a medical device that received FDA 510(k) clearance on 2025-03-18. The listed applicant is Teleflex Medical. The 510(k) number is K243553.

When did QuikClot Control+ Hemostatic Device receive FDA 510(k) clearance?

QuikClot Control+ Hemostatic Device received FDA 510(k) clearance on 2025-03-18, under 510(k) number K243553.

Who is the listed applicant for QuikClot Control+ Hemostatic Device?

FDA 510(k)记录显示Teleflex Medical为申请人。这本身并不能确立该设备制造商的身份。

What is the FDA product code for QuikClot Control+ Hemostatic Device?

The FDA product code for QuikClot Control+ Hemostatic Device is POD.

列明Teleflex Medical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。

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