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FDA 510(k)

Advance Biliary Balloon Catheter

K-Number: K173414 · 2018-06-22

ApplicantCook Incorporated
Decision Date2018-06-22
Product CodeGCA
Advisory CommitteeGU
DecisionUnknown

Device Summary

Advance Biliary Balloon Catheter is a medical device manufactured by Cook Incorporated. It received FDA 510(k) clearance on 2018-06-22 under approval number K173414. The device is classified under product code GCA. It was reviewed by the GU advisory panel. FDA Decision: Unknown.

Frequently Asked Questions

What is the Advance Biliary Balloon Catheter?

Advance Biliary Balloon Catheter is a medical device that received FDA 510(k) clearance on 2018-06-22. It is manufactured by Cook Incorporated. The 510(k) number is K173414.

When was Advance Biliary Balloon Catheter approved by the FDA?

Advance Biliary Balloon Catheter received FDA 510(k) clearance on 2018-06-22, under approval number K173414.

What company makes Advance Biliary Balloon Catheter?

Advance Biliary Balloon Catheter is manufactured by Cook Incorporated.

What is the FDA product code for Advance Biliary Balloon Catheter?

The FDA product code for Advance Biliary Balloon Catheter is GCA.

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Related Devices (Code: GCA)

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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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