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DTK — Filter, Intravascular, Cardiovascular Class II

FDA Device Classification

Classification Details

Product Code
DTK
Device Class
Class II
Regulation Number
870.3375
Submission Type
Review Panel
CV
Medical Specialty
Cardiovascular
Implant
Yes

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K242612argon medical devicesOption ELITE Vena Cava Filter System (352506070E 352506100E)September 10, 2024
K240578b.braun medicalVenaTech® LP Vena Cava Filter System and VenaTech® Convertible Vena Cava Filter July 31, 2024
K241507aln s.a.r.lALN Optional Vena Cava Filter (FB.010500, FF.010995, FJ.120096, FB.HOOK, FF.HOOKJune 26, 2024
K240257bdDenali™ Vena Cava Filter System – Femoral and Jugular/Subclavian Delivery KitFebruary 29, 2024
K233680william cook europe apsCelect Platinum Vena Cava Filter Set for Femoral Vein Approach (IGTCFS-65-1-FEM-January 18, 2024
K211874william cook europe apsGünther Tulip Vena Cava Filter Set for Femoral Vein Approach, Günther Tulip VenaJuly 28, 2021
K211875william cook europe apsCook Celect Platinum Vena Cava Filter Set for Femoral Vein Approach, Cook CelectJuly 28, 2021
K181202novate medicalSentry IVC FilterJune 6, 2018
K173236novate medicalSentry IVC FilterFebruary 22, 2018
K172557william cook europe apsGunther Tulip Vena Cava Filter Set for Femoral Vein Approach, Gunther Tulip VenaNovember 20, 2017
K172584william cook europe apsGünther Tulip Vena Cava Filter Set for Femoral Vein Approach, Günther Tulip VenaNovember 20, 2017
K163699aln implants chirurgicauxALN Optional Vena Cava Filter - Femoral Approach, ALN Optional Vena Cava Filter September 8, 2017
K171712william cook europe apsCook Celect Platinum Vena Cava Filter Set for Femoral Vein Approach, Cook CelectAugust 7, 2017
K162875novate medicalSentry IVC filterFebruary 17, 2017
K161218cook incorporatedGianturco-Roehm Bird’s Nest Vena Cava FilterJuly 22, 2016
K160866c.r. bardDenali Filter System - Femoral Delivery Kit, Denali Filter System - Jugular/SubcApril 29, 2016
K152765b. braun interventional systemsVENATECH CONVERTIBLE VENA CAVA FILTER SYSTEMFebruary 26, 2016
K143405rex medical, l.pOption (TM) ELITE Vena Cava Filter 100cm SystemApril 16, 2015
K150262volcano corporationCrux Vena Cava Filter System, femoral; Crux Vena Cava Filter System, jugularApril 3, 2015
K143208c.r. bardDenali Filter System - Femoral Delivery Kit, Denali Filter System - Jugular/SubcDecember 9, 2014