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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 the device name listed in this FDA 510(k) record. The listed applicant is Cook Incorporated. It received FDA 510(k) clearance on 2018-06-22 under 510(k) 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. The listed applicant is Cook Incorporated. The 510(k) number is K173414.

When did Advance Biliary Balloon Catheter receive FDA 510(k) clearance?

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

Who is the listed applicant for Advance Biliary Balloon Catheter?

The FDA 510(k) record lists Cook Incorporated as the applicant. This does not by itself establish the device manufacturer.

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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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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