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 ID: K200268
• 510k Number: K200268
• Device Name: Halo™ Single-Loop Snare Kit
• Classification: Device, Percutaneous Retrieval
• Applicant: Argon Medical Devices, Inc. 1445 Flat Creek Road Athens, TX 75751
• Contact: Ana Jimenez-hughes
• Correspondent: Ana Jimenez-hughes; Argon Medical Devices, Inc. 1445 Flat Creek Road Athens, TX 75751
• Product Code: MMX
• CFR Regulation Number: 870.5150 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2020-02-03
• Decision Date: 2020-06-03

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00886333224937	K200268	000
00886333224920	K200268	000
00886333224913	K200268	000
00886333224906	K200268	000
00886333224890	K200268	000
00886333224883	K200268	000
00886333224876	K200268	000
00886333224869	K200268	000
00886333224852	K200268	000