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FDA 510(k)

Gunther Tulip Vena Cava Filter Retrieval Set

K-Number: K222254 · 2023-05-16

ApplicantCook Incorporated
Decision Date2023-05-16
Product CodeMMX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Gunther Tulip Vena Cava Filter Retrieval Set is a medical device manufactured by Cook Incorporated. It received FDA 510(k) clearance on 2023-05-16 under approval number K222254. The device is classified under product code MMX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Gunther Tulip Vena Cava Filter Retrieval Set?

Gunther Tulip Vena Cava Filter Retrieval Set is a medical device that received FDA 510(k) clearance on 2023-05-16. It is manufactured by Cook Incorporated. The 510(k) number is K222254.

When was Gunther Tulip Vena Cava Filter Retrieval Set approved by the FDA?

Gunther Tulip Vena Cava Filter Retrieval Set received FDA 510(k) clearance on 2023-05-16, under approval number K222254.

What company makes Gunther Tulip Vena Cava Filter Retrieval Set?

Gunther Tulip Vena Cava Filter Retrieval Set is manufactured by Cook Incorporated.

What is the FDA product code for Gunther Tulip Vena Cava Filter Retrieval Set?

The FDA product code for Gunther Tulip Vena Cava Filter Retrieval Set is MMX.

Related Clinical Trials

NCT05881798 Post-Market Celect Platinum Vena Cava Filter and Gunther Tulip Retrieval Set Study RECRUITING

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Related Devices (Code: MMX)

K160593Indy OTW Vascular RetrieverCook Incorporated K152136Recovery Cone Removal SystemC.R. Bard, Inc. K170987Captus Vascular Retrieval SystemAvantec Vascular Corporation K163307Expro Elite Snare, Sympro Elite SnareVascular Solutions, Inc. K181757Günther Tulip® Vena Cava Filter Retrieval SetCook Incorporated K191758Single-Loop Snare Retrieval Kit, Triple-Loop Snare Retrieval KitArgon Medical Devices, Inc.

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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