FDA.reportPublic FDA data

510(k) K964284

Device
Stainless Steel Greenfield Vena Cava Filter With 12f Introducer System
Applicant
BOSTON SCIENTIFIC CORP.
510(k) number
K964284
Product code
DTK
Decision
Substantially Equivalent (SESE)
Decision date
1997-01-06
Date received
1996-10-28
Regulation
870.3375
Classification name
Filter, Intravascular, Cardiovascular
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
LAURA MONDANO
Address
One Boston Scientific Pl. Natick, MA US 01760 01760

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
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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
K163699ALN 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 HookAln Implants Chirurgicaux2017-09-08
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