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FDA 510(k)

Reliant(TM) Multistage Dilatation Balloon Catheter

K-Number: K180418 · 2018-10-15

ApplicantMicro-Tech (Nanjing) Co., Ltd.
Decision Date2018-10-15
Product CodeFGE
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Reliant(TM) Multistage Dilatation Balloon Catheter is a medical device manufactured by Micro-Tech (Nanjing) Co., Ltd.. It received FDA 510(k) clearance on 2018-10-15 under approval number K180418. 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(TM) Multistage Dilatation Balloon Catheter?

Reliant(TM) Multistage Dilatation Balloon Catheter is a medical device that received FDA 510(k) clearance on 2018-10-15. It is manufactured by Micro-Tech (Nanjing) Co., Ltd.. The 510(k) number is K180418.

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

Reliant(TM) Multistage Dilatation Balloon Catheter received FDA 510(k) clearance on 2018-10-15, under approval number K180418.

What company makes Reliant(TM) Multistage Dilatation Balloon Catheter?

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

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

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

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

K162466LuminScan (TM) Imaging System K160625Disposable Hot Biopsy Forceps K152802Grasping Forceps K172309Endoscopic Ultrasound Aspiration Needle K162226Reliant Multistage Dilatation Balloon Catheter K161463SureClip(TM) Repositionable Hemostasis Clip

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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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