FDA 510(k)

AMT 低轮廓耻骨上导尿管及引流套装

K号: K240514 · 2024-11-01

决定日期2024-11-01

产品代码KOB

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决定实质等同

器械摘要

AMT Low-Profile Suprapubic Catheter & Drainage Set is the device name listed in this FDA 510(k) record. The listed applicant is Applied Medical Technology, Inc.. It received FDA 510(k) clearance on 2024-11-01 under 510(k) number K240514. The device is classified under product code KOB. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the AMT Low-Profile Suprapubic Catheter & Drainage Set?

AMT Low-Profile Suprapubic Catheter & Drainage Set is a medical device that received FDA 510(k) clearance on 2024-11-01. The listed applicant is Applied Medical Technology, Inc.. The 510(k) number is K240514.

When did AMT Low-Profile Suprapubic Catheter & Drainage Set receive FDA 510(k) clearance?

AMT Low-Profile Suprapubic Catheter & Drainage Set received FDA 510(k) clearance on 2024-11-01, under 510(k) number K240514.

Who is the listed applicant for AMT Low-Profile Suprapubic Catheter & Drainage Set?

The FDA 510(k) record lists Applied Medical Technology, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AMT Low-Profile Suprapubic Catheter & Drainage Set?

The FDA product code for AMT Low-Profile Suprapubic Catheter & Drainage Set is KOB.

列明Applied Medical Technology, Inc.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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