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FDA 510(k)

Vado Steerable Sheath

K-Number: K160721 · 2017-03-07

ApplicantKalila Medical, Inc.
Decision Date2017-03-07
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Vado Steerable Sheath is a medical device manufactured by Kalila Medical, Inc.. It received FDA 510(k) clearance on 2017-03-07 under approval number K160721. 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 Vado Steerable Sheath?

Vado Steerable Sheath is a medical device that received FDA 510(k) clearance on 2017-03-07. It is manufactured by Kalila Medical, Inc.. The 510(k) number is K160721.

When was Vado Steerable Sheath approved by the FDA?

Vado Steerable Sheath received FDA 510(k) clearance on 2017-03-07, under approval number K160721.

What company makes Vado Steerable Sheath?

Vado Steerable Sheath is manufactured by Kalila Medical, Inc..

What is the FDA product code for Vado Steerable Sheath?

The FDA product code for Vado Steerable Sheath is DYB.

Other Devices by Kalila Medical, Inc.

K162427Vado Bi-Directional Steerable Sheath

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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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