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FDA 510(k)

Transjugular Liver Access Sets

K-Number: K171820 · 2018-03-09

ApplicantCook Incorporated
Decision Date2018-03-09
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Transjugular Liver Access Sets is the device name listed in this FDA 510(k) record. The listed applicant is Cook Incorporated. It received FDA 510(k) clearance on 2018-03-09 under 510(k) number K171820. The device is classified under product code DYB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Transjugular Liver Access Sets?

Transjugular Liver Access Sets is a medical device that received FDA 510(k) clearance on 2018-03-09. The listed applicant is Cook Incorporated. The 510(k) number is K171820.

When did Transjugular Liver Access Sets receive FDA 510(k) clearance?

Transjugular Liver Access Sets received FDA 510(k) clearance on 2018-03-09, under 510(k) number K171820.

Who is the listed applicant for Transjugular Liver Access Sets?

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 Transjugular Liver Access Sets?

The FDA product code for Transjugular Liver Access Sets is DYB.

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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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