FDA 510(k)

Gianturco-Roehm Bird’s Nest Vena Cava Filter

K-Number: K161218 · 2016-07-22

Decision Date2016-07-22

Product CodeDTK

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

Gianturco-Roehm Bird’s Nest Vena Cava Filter is the device name listed in this FDA 510(k) record. The listed applicant is Cook Incorporated. It received FDA 510(k) clearance on 2016-07-22 under 510(k) number K161218. 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 Gianturco-Roehm Bird’s Nest Vena Cava Filter?

Gianturco-Roehm Bird’s Nest Vena Cava Filter is a medical device that received FDA 510(k) clearance on 2016-07-22. The listed applicant is Cook Incorporated. The 510(k) number is K161218.

When did Gianturco-Roehm Bird’s Nest Vena Cava Filter receive FDA 510(k) clearance?

Gianturco-Roehm Bird’s Nest Vena Cava Filter received FDA 510(k) clearance on 2016-07-22, under 510(k) number K161218.

Who is the listed applicant for Gianturco-Roehm Bird’s Nest Vena Cava Filter?

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

What is the FDA product code for Gianturco-Roehm Bird’s Nest Vena Cava Filter?

The FDA product code for Gianturco-Roehm Bird’s Nest Vena Cava Filter is DTK.

Related Clinical Trials

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NCT05785676ALN OATF Vena Cava FilterCOMPLETED NCT05881798Post-Market Celect Platinum Vena Cava Filter and Gunther Tulip Retrieval Set StudyRECRUITING

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PMA P020018SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT K233177Nest VT Vitrification Device K222254Gunther Tulip Vena Cava Filter Retrieval Set K223098Bakri Essential Postpartum Balloon K210734Endovascular Dilator and Sets K203670Extra Large Check-Flo Introducer

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Related Devices (Code: DTK)

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.K240257Denali™ Vena Cava Filter System – Femoral and Jugular/Subclavian Delivery KitBd 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 Aps K211875Cook 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 Aps

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.