FDA 510(k)

Codman一次性穿孔器

K号: K183581 · 2019-01-20

决定日期2019-01-20

产品代码HBF

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决定实质等同

器械摘要

Codman Disposable Perforators is the device name listed in this FDA 510(k) record. The listed applicant is Integra Lifesciences Corp.. It received FDA 510(k) clearance on 2019-01-20 under 510(k) number K183581. The device is classified under product code HBF. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Codman Disposable Perforators?

Codman Disposable Perforators is a medical device that received FDA 510(k) clearance on 2019-01-20. The listed applicant is Integra Lifesciences Corp.. The 510(k) number is K183581.

When did Codman Disposable Perforators receive FDA 510(k) clearance?

Codman Disposable Perforators received FDA 510(k) clearance on 2019-01-20, under 510(k) number K183581.

Who is the listed applicant for Codman Disposable Perforators?

The FDA 510(k) record lists Integra Lifesciences Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Codman Disposable Perforators?

The FDA product code for Codman Disposable Perforators is HBF.

列明Integra Lifesciences Corp.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。

K183406CereLink ICP 监测仪，CereLink ICP 延长线 K182265CodMan Certas Plus可编程阀门 K181902Codman Certas Plus电子工具包

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