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FDA 510(k)

Brite Tip Radianz Guiding Sheath

K-Number: K202167 · 2021-02-26

ApplicantCordis Corporation
Decision Date2021-02-26
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Brite Tip Radianz Guiding Sheath is a medical device manufactured by Cordis Corporation. It received FDA 510(k) clearance on 2021-02-26 under approval number K202167. 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 Brite Tip Radianz Guiding Sheath?

Brite Tip Radianz Guiding Sheath is a medical device that received FDA 510(k) clearance on 2021-02-26. It is manufactured by Cordis Corporation. The 510(k) number is K202167.

When was Brite Tip Radianz Guiding Sheath approved by the FDA?

Brite Tip Radianz Guiding Sheath received FDA 510(k) clearance on 2021-02-26, under approval number K202167.

What company makes Brite Tip Radianz Guiding Sheath?

Brite Tip Radianz Guiding Sheath is manufactured by Cordis Corporation.

What is the FDA product code for Brite Tip Radianz Guiding Sheath?

The FDA product code for Brite Tip Radianz Guiding Sheath 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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