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FDA 510(k)

Halo™ Single-Loop Snare Kit

K-Number: K200268 · 2020-06-03

ApplicantArgon Medical Devices, Inc.
Decision Date2020-06-03
Product CodeMMX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Halo™ Single-Loop Snare Kit is the device name listed in this FDA 510(k) record. The listed applicant is Argon Medical Devices, Inc.. It received FDA 510(k) clearance on 2020-06-03 under 510(k) number K200268. 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 Halo™ Single-Loop Snare Kit?

Halo™ Single-Loop Snare Kit is a medical device that received FDA 510(k) clearance on 2020-06-03. The listed applicant is Argon Medical Devices, Inc.. The 510(k) number is K200268.

When did Halo™ Single-Loop Snare Kit receive FDA 510(k) clearance?

Halo™ Single-Loop Snare Kit received FDA 510(k) clearance on 2020-06-03, under 510(k) number K200268.

Who is the listed applicant for Halo™ Single-Loop Snare Kit?

The FDA 510(k) record lists Argon Medical Devices, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Halo™ Single-Loop Snare Kit?

The FDA product code for Halo™ Single-Loop Snare Kit is MMX.

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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.K222254Gunther Tulip Vena Cava Filter Retrieval SetCook IncorporatedK222083LimFlow V-CeiverLimFlow, Inc.K212988ONO Retrieval DeviceOnocor Vascular, LLC

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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