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 a medical device manufactured by Merit Medical Systems, Inc.. It received FDA 510(k) clearance on 2020-01-17 under approval 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. It is manufactured by Merit Medical Systems, Inc.. The 510(k) number is K193507.
When was Merit ONE Snare System approved by the FDA?
Merit ONE Snare System received FDA 510(k) clearance on 2020-01-17, under approval number K193507.
What company makes Merit ONE Snare System?
Merit ONE Snare System is manufactured by Merit Medical Systems, Inc..
What is the FDA product code for Merit ONE Snare System?
The FDA product code for Merit ONE Snare System is MMX.
Other Devices by Merit Medical Systems, Inc.
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.