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FDA 510(k)

Option ELITE Vena Cava Filter System (352506070E 352506100E)

K-Number: K242612 · 2024-09-10

ApplicantArgon Medical Devices, Inc.
Decision Date2024-09-10
Product CodeDTK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Option ELITE Vena Cava Filter System (352506070E 352506100E) is a medical device manufactured by Argon Medical Devices, Inc.. It received FDA 510(k) clearance on 2024-09-10 under approval number K242612. 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 Option ELITE Vena Cava Filter System (352506070E 352506100E)?

Option ELITE Vena Cava Filter System (352506070E 352506100E) is a medical device that received FDA 510(k) clearance on 2024-09-10. It is manufactured by Argon Medical Devices, Inc.. The 510(k) number is K242612.

When was Option ELITE Vena Cava Filter System (352506070E 352506100E) approved by the FDA?

Option ELITE Vena Cava Filter System (352506070E 352506100E) received FDA 510(k) clearance on 2024-09-10, under approval number K242612.

What company makes Option ELITE Vena Cava Filter System (352506070E 352506100E)?

Option ELITE Vena Cava Filter System (352506070E 352506100E) is manufactured by Argon Medical Devices, Inc..

What is the FDA product code for Option ELITE Vena Cava Filter System (352506070E 352506100E)?

The FDA product code for Option ELITE Vena Cava Filter System (352506070E 352506100E) is DTK.

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Related Devices (Code: DTK)

K161218Gianturco-Roehm Bird’s Nest Vena Cava FilterCook Incorporated K160866Denali Filter System - Femoral Delivery Kit, Denali Filter System - Jugular/Subclavian Delivery KitC.R. Bard, Inc. K152765VENATECH CONVERTIBLE VENA CAVA FILTER SYSTEMB. Braun Interventional Systems, Inc. K172584Günther Tulip Vena Cava Filter Set for Femoral Vein Approach, Günther Tulip Vena Cava Filter Set for Femoral and Jugular Vein ApproachWilliam Cook Europe Aps 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 Aps 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 Chirurgicaux

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.

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