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FDA 510(k)

Merit ONE Snare System

K-Number: K193507 · 2020-01-17

ApplicantMerit Medical Systems, Inc.
Decision Date2020-01-17
Product CodeMMX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Merit ONE Snare System is the device name listed in this FDA 510(k) record. The listed applicant is Merit Medical Systems, Inc.. It received FDA 510(k) clearance on 2020-01-17 under 510(k) number K193507. 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 Merit ONE Snare System?

Merit ONE Snare System is a medical device that received FDA 510(k) clearance on 2020-01-17. The listed applicant is Merit Medical Systems, Inc.. The 510(k) number is K193507.

When did Merit ONE Snare System receive FDA 510(k) clearance?

Merit ONE Snare System received FDA 510(k) clearance on 2020-01-17, under 510(k) number K193507.

Who is the listed applicant for Merit ONE Snare System?

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

What is the FDA product code for Merit ONE Snare System?

The FDA product code for Merit ONE Snare System 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.

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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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