FDA 510(k)

In-Ka Percutaneous Balloon Dilatation Catheters, Amplatz Sheath

K号: K201165 · 2020-12-17

决定日期2020-12-17

产品代码LJE

决定Unknown

器械摘要

In-Ka Percutaneous Balloon Dilatation Catheters, Amplatz Sheath is the device name listed in this FDA 510(k) record. The listed applicant is Coloplast Corp.. It received FDA 510(k) clearance on 2020-12-17 under 510(k) number K201165. The device is classified under product code LJE. FDA Decision: Unknown.

常见问题

What is the In-Ka Percutaneous Balloon Dilatation Catheters, Amplatz Sheath?

In-Ka Percutaneous Balloon Dilatation Catheters, Amplatz Sheath is a medical device that received FDA 510(k) clearance on 2020-12-17. The listed applicant is Coloplast Corp.. The 510(k) number is K201165.

When did In-Ka Percutaneous Balloon Dilatation Catheters, Amplatz Sheath receive FDA 510(k) clearance?

In-Ka Percutaneous Balloon Dilatation Catheters, Amplatz Sheath received FDA 510(k) clearance on 2020-12-17, under 510(k) number K201165.

Who is the listed applicant for In-Ka Percutaneous Balloon Dilatation Catheters, Amplatz Sheath?

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

What is the FDA product code for In-Ka Percutaneous Balloon Dilatation Catheters, Amplatz Sheath?

The FDA product code for In-Ka Percutaneous Balloon Dilatation Catheters, Amplatz Sheath is LJE.

列明Coloplast Corp.为申报人的其他记录

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相关器械（代码：LJE）

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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