FDA 510(k)

球囊扩张导管

K号: K213578 · 2022-04-06

决定日期2022-04-06

产品代码FDF

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决定实质等同

器械摘要

Balloon Dilatation Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Hangzhou AGS MedTech Co., Ltd.. It received FDA 510(k) clearance on 2022-04-06 under 510(k) number K213578. The device is classified under product code FDF. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Balloon Dilatation Catheter?

Balloon Dilatation Catheter is a medical device that received FDA 510(k) clearance on 2022-04-06. The listed applicant is Hangzhou AGS MedTech Co., Ltd.. The 510(k) number is K213578.

When did Balloon Dilatation Catheter receive FDA 510(k) clearance?

Balloon Dilatation Catheter received FDA 510(k) clearance on 2022-04-06, under 510(k) number K213578.

Who is the listed applicant for Balloon Dilatation Catheter?

FDA 510(k)记录将杭州AGS医械科技有限公司列为申请人。这本身并不足以确立该设备制造商的身份。

What is the FDA product code for Balloon Dilatation Catheter?

The FDA product code for Balloon Dilatation Catheter is FDF.

列明Hangzhou AGS MedTech Co., Ltd.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。

K254069血液夹（511系列，543系列）K253393一次性球囊扩张导管（AG-5251-083018 AG-5251-085518 AG-5251-088018 AG-5251-083019 AG-5251-085519 AG-5251-088019 AG-5251-083021 AG-5251-085521 AG-5251-088021 AG-5251-083024 AG-5251-085524 AG-5251-088024 AG-5251-103018 AG-5251-105518 AG-5251-108018 AG-5251-103019 AG-5251-105519 AG-5251-108019 AG-5251-103021 AG-5251-105521 AG-5251-108021 AG-5251-103024 AG-5251-105524 AG-5251-108024 AG-5251-123018 AG-5251-125518 AG-5251-128018 AG-5251-123019 AG-5251-125519 AG-5251-128019）K252270Hemoclip K252271Hemoclip K241704内镜水泵 K222421Sphincterotome

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