FDA 510(k)

Denali Filter System - Femoral Delivery Kit, Denali Filter System - Jugular/Subclavian Delivery Kit

K-Number: K160866 · 2016-04-29

Decision Date2016-04-29

Product CodeDTK

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

Denali Filter System - Femoral Delivery Kit, Denali Filter System - Jugular/Subclavian Delivery Kit is a medical device manufactured by C.R. Bard, Inc.. It received FDA 510(k) clearance on 2016-04-29 under approval number K160866. The device is classified under product code DTK. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Denali Filter System - Femoral Delivery Kit, Denali Filter System - Jugular/Subclavian Delivery Kit?

Denali Filter System - Femoral Delivery Kit, Denali Filter System - Jugular/Subclavian Delivery Kit is a medical device that received FDA 510(k) clearance on 2016-04-29. It is manufactured by C.R. Bard, Inc.. The 510(k) number is K160866.

When was Denali Filter System - Femoral Delivery Kit, Denali Filter System - Jugular/Subclavian Delivery Kit approved by the FDA?

Denali Filter System - Femoral Delivery Kit, Denali Filter System - Jugular/Subclavian Delivery Kit received FDA 510(k) clearance on 2016-04-29, under approval number K160866.

What company makes Denali Filter System - Femoral Delivery Kit, Denali Filter System - Jugular/Subclavian Delivery Kit?

Denali Filter System - Femoral Delivery Kit, Denali Filter System - Jugular/Subclavian Delivery Kit is manufactured by C.R. Bard, Inc..

What is the FDA product code for Denali Filter System - Femoral Delivery Kit, Denali Filter System - Jugular/Subclavian Delivery Kit?

The FDA product code for Denali Filter System - Femoral Delivery Kit, Denali Filter System - Jugular/Subclavian Delivery Kit is DTK.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.