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FDA 510(k)

Denali™ Vena Cava Filter System – Femoral and Jugular/Subclavian Delivery Kit

K-Number: K240257 · 2024-02-29

ApplicantBd
Decision Date2024-02-29
Product CodeDTK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Denali™ Vena Cava Filter System – Femoral and Jugular/Subclavian Delivery Kit is the device name listed in this FDA 510(k) record. The listed applicant is Bd. It received FDA 510(k) clearance on 2024-02-29 under 510(k) number K240257. 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™ Vena Cava Filter System – Femoral and Jugular/Subclavian Delivery Kit?

Denali™ Vena Cava Filter System – Femoral and Jugular/Subclavian Delivery Kit is a medical device that received FDA 510(k) clearance on 2024-02-29. The listed applicant is Bd. The 510(k) number is K240257.

When did Denali™ Vena Cava Filter System – Femoral and Jugular/Subclavian Delivery Kit receive FDA 510(k) clearance?

Denali™ Vena Cava Filter System – Femoral and Jugular/Subclavian Delivery Kit received FDA 510(k) clearance on 2024-02-29, under 510(k) number K240257.

Who is the listed applicant for Denali™ Vena Cava Filter System – Femoral and Jugular/Subclavian Delivery Kit?

The FDA 510(k) record lists Bd as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Denali™ Vena Cava Filter System – Femoral and Jugular/Subclavian Delivery Kit?

The FDA product code for Denali™ Vena Cava Filter System – Femoral and Jugular/Subclavian Delivery Kit is DTK.

Related Clinical Trials

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NCT02600936Sinai Vein Stent RegistryRECRUITINGNCT05785676ALN OATF Vena Cava FilterCOMPLETEDNCT05881798Post-Market Celect Platinum Vena Cava Filter and Gunther Tulip Retrieval Set StudyRECRUITINGNCT06137807TRIcvalve biCAVal Valve System for Severe Tricuspid Regurgitation (TRICAV-I)ACTIVE_NOT_RECRUITING

Other records listing Bd as applicant

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Related Devices (Code: DTK)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K242612Option ELITE Vena Cava Filter System (352506070E 352506100E)Argon Medical Devices, Inc.K240578VenaTech® LP Vena Cava Filter System and VenaTech® Convertible Vena Cava Filter SystemB.Braun Medical, Inc.K241507ALN Optional Vena Cava Filter (FB.010500, FF.010995, FJ.120096, FB.HOOK, FF.HOOK, FJ.HOOK)Aln S.A.R.L.K233680Celect Platinum Vena Cava Filter Set for Femoral Vein Approach (IGTCFS-65-1-FEM-CELECT-PT); Celect Platinum Vena Cava Filter Set for Jugular Vein Approach (IGTCFS-65-1-JUG-CELECT-PT); Celect Platinum Vena Cava Filter Set for Femoral and Jugular Vein Approach (IGTCFS-65-1-UNI-CELECT-PT); Günther Tulip Vena Cava Filter Set for Femoral Vein Approach (IGTCFS-65-1-FEM-TULIP); Günther Tulip Vena Cava Filter Set for Jugular Vein Approach (IGTCFS-65-1-JUG-TULIP); Günther Tulip Vena Cava FilterWilliam Cook Europe ApsK211875Cook Celect Platinum Vena Cava Filter Set for Femoral Vein Approach, Cook Celect Platinum Vena Cava Filte Set for Jugular Vein Approach, Cook Celect Platinum Vena Cava Filter Set for Femoral and Jugular Vein ApproachWilliam Cook Europe ApsK211874Günther Tulip Vena Cava Filter Set for Femoral Vein Approach, Günther Tulip Vena Cava Filter Set for Jugular Vein Approach, Günther Tulip Vena Cava Filter Set for Femoral and Jugular Vein ApproachWilliam Cook Europe Aps

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.

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