Halo™ Single-Loop Snare Kit

Device, Percutaneous Retrieval

Argon Medical Devices, Inc.

The following data is part of a premarket notification filed by Argon Medical Devices, Inc. with the FDA for Halo™ Single-loop Snare Kit.

Pre-market Notification Details

Device IDK200268
510k NumberK200268
Device Name:Halo™ Single-Loop Snare Kit
ClassificationDevice, Percutaneous Retrieval
Applicant Argon Medical Devices, Inc. 1445 Flat Creek Road Athens,  TX  75751
ContactAna Jimenez-hughes
CorrespondentAna Jimenez-hughes
Argon Medical Devices, Inc. 1445 Flat Creek Road Athens,  TX  75751
Product CodeMMX  
CFR Regulation Number870.5150 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-02-03
Decision Date2020-06-03

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