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FDA 510(k)

CRE RX Biliary Balloon Dilatation Catheter

K-Number: K172520 · 2017-10-04

ApplicantBoston Scientific Corporation
Decision Date2017-10-04
Product CodeFGE
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

CRE RX Biliary Balloon Dilatation Catheter is a medical device manufactured by Boston Scientific Corporation. It received FDA 510(k) clearance on 2017-10-04 under approval number K172520. 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 CRE RX Biliary Balloon Dilatation Catheter?

CRE RX Biliary Balloon Dilatation Catheter is a medical device that received FDA 510(k) clearance on 2017-10-04. It is manufactured by Boston Scientific Corporation. The 510(k) number is K172520.

When was CRE RX Biliary Balloon Dilatation Catheter approved by the FDA?

CRE RX Biliary Balloon Dilatation Catheter received FDA 510(k) clearance on 2017-10-04, under approval number K172520.

What company makes CRE RX Biliary Balloon Dilatation Catheter?

CRE RX Biliary Balloon Dilatation Catheter is manufactured by Boston Scientific Corporation.

What is the FDA product code for CRE RX Biliary Balloon Dilatation Catheter?

The FDA product code for CRE RX Biliary Balloon Dilatation Catheter is FGE.

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Other Devices by Boston Scientific Corporation

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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. K171809Epic Biliary Endoscopic Stent SystemBoston 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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