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FDA 510(k)

WallFlex Biliary PLUS RX Stent System

K-Number: K242950 · 2024-12-06

ApplicantBoston Scientific
Decision Date2024-12-06
Product CodeFGE
Advisory CommitteeGU
DecisionUnknown

Device Summary

WallFlex Biliary PLUS RX Stent System is a medical device manufactured by Boston Scientific. It received FDA 510(k) clearance on 2024-12-06 under approval number K242950. The device is classified under product code FGE. It was reviewed by the GU advisory panel. FDA Decision: Unknown.

Frequently Asked Questions

What is the WallFlex Biliary PLUS RX Stent System?

WallFlex Biliary PLUS RX Stent System is a medical device that received FDA 510(k) clearance on 2024-12-06. It is manufactured by Boston Scientific. The 510(k) number is K242950.

When was WallFlex Biliary PLUS RX Stent System approved by the FDA?

WallFlex Biliary PLUS RX Stent System received FDA 510(k) clearance on 2024-12-06, under approval number K242950.

What company makes WallFlex Biliary PLUS RX Stent System?

WallFlex Biliary PLUS RX Stent System is manufactured by Boston Scientific.

What is the FDA product code for WallFlex Biliary PLUS RX Stent System?

The FDA product code for WallFlex Biliary PLUS RX Stent System is FGE.

Related Clinical Trials

NCT03736226 A Post-Approval, Single-Arm Study of the SYNERGY Stent System in China ACTIVE_NOT_RECRUITING NCT07607353 Biodegradable Stents in Primary Sclerosing Cholangitis RECRUITING NCT06170606 POLARx Post Approval Study (POLARx PAS) ACTIVE_NOT_RECRUITING NCT07611968 Prospective Evaluation of Physician Modified Endografts for Aortic Disease NOT_YET_RECRUITING NCT05864560 Ankura™ AAA, Cuff and AUI Stent Graft System Post-Market Clinical Follow-Up ACTIVE_NOT_RECRUITING NCT05546372 Endobiliary Radiofrequency Ablation for Malignant Biliary Obstruction Due to Perihilar Cholangiocarcinoma RECRUITING

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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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