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510(k) K163699

Device
ALN Optional Vena Cava Filter - Femoral Approach, ALN Optional Vena Cava Filter - Jugular Approach, ALN Optional Vena Cava Filter - Brachial Approach, ALN Optional Vena Cava Filter - Femoral Approach With Hook
Applicant
ALN Implants Chirurgicaux
510(k) number
K163699
Product code
DTK  
Decision
Substantially Equivalent (SESE)
Decision date
2017-09-08
Date received
2016-12-29
Regulation
870.3375
Classification name
Filter, Intravascular, Cardiovascular
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Abbreviated
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Alain Nigon
Address
589 Chemin Du Niel Bormes Les Mimosas FR 83230 83230

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code DTK  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K242612Option ELITE Vena Cava Filter System (352506070E 352506100E)Argon Medical Devices, Inc.2024-09-10
K240578VenaTech® LP Vena Cava Filter System and VenaTech® Convertible Vena Cava Filter SystemB.Braun Medical, Inc.2024-07-31
K241507ALN Optional Vena Cava Filter (FB.010500, FF.010995, FJ.120096, FB.HOOK, FF.HOOK, FJ.HOOK)Aln S.A.R.L.2024-06-26
K240257Denali™ Vena Cava Filter System – Femoral and Jugular/Subclavian Delivery KitBd2024-02-29
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 Aps2024-01-18
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 Aps2021-07-28
K211874Günther 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 Aps2021-07-28
K181202Sentry IVC FilterNovate Medical , Ltd.2018-06-06
K173236Sentry IVC FilterNovate Medical , Ltd.2018-02-22
K172584Günther Tulip Vena Cava Filter Set for Femoral Vein Approach, Günther Tulip Vena Cava Filter Set for Femoral and Jugular Vein ApproachWilliam Cook Europe Aps2017-11-20
K172557Gunther Tulip Vena Cava Filter Set for Femoral Vein Approach, Gunther Tulip Vena Cava Filter Set for Jugular Vein Approach, Gunther Tulip Vena Cava Filter Set for Femoral and Jugular Vein ApproachWilliam Cook Europe Aps2017-11-20
K171712Cook Celect Platinum Vena Cava Filter Set for Femoral Vein Approach, Cook Celect Platinum Vena Cava Filter Set for Jugular Vein Approach, Cook Celect Platinum Vena Cava Filter Set for Femoral and Jugular Vein ApproachWilliam Cook Europe Aps2017-08-07
K162875Sentry IVC filterNovate Medical , Ltd.2017-02-17
K161218Gianturco-Roehm Bird’s Nest Vena Cava FilterCook Incorporated2016-07-22
K160866Denali Filter System - Femoral Delivery Kit, Denali Filter System - Jugular/Subclavian Delivery KitC.R. Bard, Inc.2016-04-29

Legacy Summary#

summary

FDA Review#

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