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FDA 510(k)

Reliant Multistage Dilatation Balloon Catheter

K-Number: K162226 · 2017-01-25

ApplicantMicro-Tech (Nanjing) Co., Ltd.
Decision Date2017-01-25
Product CodeFGE
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Reliant Multistage Dilatation Balloon Catheter is a medical device manufactured by Micro-Tech (Nanjing) Co., Ltd.. It received FDA 510(k) clearance on 2017-01-25 under approval number K162226. 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 Reliant Multistage Dilatation Balloon Catheter?

Reliant Multistage Dilatation Balloon Catheter is a medical device that received FDA 510(k) clearance on 2017-01-25. It is manufactured by Micro-Tech (Nanjing) Co., Ltd.. The 510(k) number is K162226.

When was Reliant Multistage Dilatation Balloon Catheter approved by the FDA?

Reliant Multistage Dilatation Balloon Catheter received FDA 510(k) clearance on 2017-01-25, under approval number K162226.

What company makes Reliant Multistage Dilatation Balloon Catheter?

Reliant Multistage Dilatation Balloon Catheter is manufactured by Micro-Tech (Nanjing) Co., Ltd..

What is the FDA product code for Reliant Multistage Dilatation Balloon Catheter?

The FDA product code for Reliant Multistage Dilatation Balloon Catheter is FGE.

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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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