Merit ONE Snare System

Device, Percutaneous Retrieval

Merit Medical Systems, Inc.

The following data is part of a premarket notification filed by Merit Medical Systems, Inc. with the FDA for Merit One Snare System.

Pre-market Notification Details

Device IDK193507
510k NumberK193507
Device Name:Merit ONE Snare System
ClassificationDevice, Percutaneous Retrieval
Applicant Merit Medical Systems, Inc. Parkmore Business Park West Galway,  IE
ContactMark Mullaney
CorrespondentMichael O'sullivan
Merit Medical Systems, Inc. Parkmore Business Park West Galway,  IE
Product CodeMMX  
CFR Regulation Number870.5150 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyCardiovascular
510k Review PanelCardiovascular
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-12-18
Decision Date2020-01-17

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