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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 the device name listed in this FDA 510(k) record. The listed applicant is Cook Incorporated. It received FDA 510(k) clearance on 2023-05-16 under 510(k) 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. The listed applicant is Cook Incorporated. The 510(k) number is K222254.

When did Gunther Tulip Vena Cava Filter Retrieval Set receive FDA 510(k) clearance?

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

Who is the listed applicant for Gunther Tulip Vena Cava Filter Retrieval Set?

The FDA 510(k) record lists Cook Incorporated as the applicant. This does not by itself establish the device manufacturer.

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

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT05881798Post-Market Celect Platinum Vena Cava Filter and Gunther Tulip Retrieval Set StudyRECRUITINGNCT05785676ALN OATF Vena Cava FilterCOMPLETED

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Related Devices (Code: MMX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K242776LimFlow V-CeiverLimFlow, Inc.K241259Amplatz Goose Neck Snare KitMedtronic, Inc.K232443Single-Loop Snare Retrieval Kit, Triple-Loop Snare Retrieval KitArgon Medical Devices, Inc.K222083LimFlow V-CeiverLimFlow, Inc.K212988ONO Retrieval DeviceOnocor Vascular, LLCK213494Aveir Retrieval CatheterABBOTT MEDICAL

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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