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FDA 510(k)

Balloon Dilatation Catheter

K-Number: K213578 · 2022-04-06

ApplicantHangzhou AGS MedTech Co., Ltd.
Decision Date2022-04-06
Product CodeFDF
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

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

Frequently Asked Questions

What is the Balloon Dilatation Catheter?

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

When was Balloon Dilatation Catheter approved by the FDA?

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

What company makes Balloon Dilatation Catheter?

Balloon Dilatation Catheter is manufactured by Hangzhou AGS MedTech Co., Ltd..

What is the FDA product code for Balloon Dilatation Catheter?

The FDA product code for Balloon Dilatation Catheter is FDF.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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