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FDA 510(k)

Dilation Balloon Catheter

K-Number: K253832 · 2026-04-24

ApplicantMirco-Tech (Nanjing) Co., Ltd.
Decision Date2026-04-24
Product CodeFGE
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Dilation Balloon Catheter is a medical device manufactured by Mirco-Tech (Nanjing) Co., Ltd.. It received FDA 510(k) clearance on 2026-04-24 under approval number K253832. The device is classified under product code FGE. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Dilation Balloon Catheter?

Dilation Balloon Catheter is a medical device that received FDA 510(k) clearance on 2026-04-24. It is manufactured by Mirco-Tech (Nanjing) Co., Ltd.. The 510(k) number is K253832.

When was Dilation Balloon Catheter approved by the FDA?

Dilation Balloon Catheter received FDA 510(k) clearance on 2026-04-24, under approval number K253832.

What company makes Dilation Balloon Catheter?

Dilation Balloon Catheter is manufactured by Mirco-Tech (Nanjing) Co., Ltd..

What is the FDA product code for Dilation Balloon Catheter?

The FDA product code for Dilation Balloon Catheter is FGE.

Related Clinical Trials

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Other Devices by Mirco-Tech (Nanjing) Co., Ltd.

K233772Disposable Dual Action Tissue Closure Device K254153Single-use Video Scope; PB Digital Controller K253139Disposable Distal Cap

Related Devices (Code: FGE)

K163018Zilver 635 Biliary StentCook Ireland, Ltd. K162404Express SD Biliary Monorail Premounted Stent SystemBoston Scientific Corporation K161203Soehendra Stent RetrieverWilson-Cook Medical, Inc. K150487X-Suit NIR Biliary Metallic StentMedinol, Ltd. K171548Cotton Graduated Dilation Catheter, Fusion Biliary Dilation Catheter, Soehendra Biliary Dilation Catheter, Geenen Graduated Dilation CatheterWilson-Cook Medical, Inc. K172520CRE RX Biliary Balloon Dilatation CatheterBoston Scientific Corporation

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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