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Bard Denali Filter System - Femoral Delivery Kit and Jugular Delivery Kit

FDA 510(k)

Class II (US FDA 510(k))

510(k) K130366

by C. R. Bard, Inc.

Identifiers

510(k) Number
K130366 FDA 510(k)
FDA Product Code
DTK FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 870.3375 FDA 510(k)
Regulation Number
870.3375 FDA 510(k)
Advisory Committee
Cardiovascular FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Bard Denali Filter System is an intravascular cardiovascular device that includes both femoral and jugular delivery kits. It is designed for the placement of vena cava filters to prevent pulmonary embolism in patients at risk for venous thromboembolism.

The system is supplied as a sterile, single-use device and includes components such as an introducer sheath, dilator, and pusher. It is classified as a Class II medical device and has received FDA 510(k) clearance with the product code DTK.

Frequently asked questions

What is the Bard Denali Filter System used for?

The Bard Denali Filter System is an intravascular cardiovascular device designed for the placement of vena cava filters to prevent pulmonary embolism in patients at risk for venous thromboembolism.

How is the Bard Denali Filter System supplied?

The system is supplied as a sterile, single-use device and includes components such as an introducer sheath, dilator, and pusher.

What is the regulatory classification of the Bard Denali Filter System?

The Bard Denali Filter System is classified as a Class II medical device and has received FDA 510(k) clearance with the product code DTK.

What delivery options are available for the Bard Denali Filter System?

The Bard Denali Filter System includes both femoral and jugular delivery kits for the placement of vena cava filters.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Denali™ Vena Cava Filter - DL900J | BD, Denali™ Vena Cava Filter, Femoral Delivery Kit - DL900F | BD, Bard Denali Filter System- Femoral Delivery Kit and Jugular Delivery ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
C. R. Bard, Inc.
FDA Applicant
C.R. Bard, Inc.

Sources (1)

  • FDA 510(k) K130366 24 fields · synced Sep 19, 2026