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FDA 510(k)

Quantum TTC Biliary Balloon Dilator

K-Number: K171223 · 2017-06-16

ApplicantWilson-Cook Medical, Inc.
Decision Date2017-06-16
Product CodeFGE
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Quantum TTC Biliary Balloon Dilator is a medical device manufactured by Wilson-Cook Medical, Inc.. It received FDA 510(k) clearance on 2017-06-16 under approval number K171223. 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 Quantum TTC Biliary Balloon Dilator?

Quantum TTC Biliary Balloon Dilator is a medical device that received FDA 510(k) clearance on 2017-06-16. It is manufactured by Wilson-Cook Medical, Inc.. The 510(k) number is K171223.

When was Quantum TTC Biliary Balloon Dilator approved by the FDA?

Quantum TTC Biliary Balloon Dilator received FDA 510(k) clearance on 2017-06-16, under approval number K171223.

What company makes Quantum TTC Biliary Balloon Dilator?

Quantum TTC Biliary Balloon Dilator is manufactured by Wilson-Cook Medical, Inc..

What is the FDA product code for Quantum TTC Biliary Balloon Dilator?

The FDA product code for Quantum TTC Biliary Balloon Dilator is FGE.

Other Devices by Wilson-Cook Medical, Inc.

K160170Lehman Manometry Catheter K161203Soehendra Stent Retriever K171573Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brush K171548Cotton Graduated Dilation Catheter, Fusion Biliary Dilation Catheter, Soehendra Biliary Dilation Catheter, Geenen Graduated Dilation Catheter K170292Tri-Ex Extraction Balloon With Multiple Sizing K171596ECHO-3-22: Echotip Ultra and EUSN-1, EUSN-3: Echotip Ultrasound Needle

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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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