510(k) K200963

Halo Single-Loop Microsnare Kit by Argon Medical Devices, Inc. — Product Code MMX

K200963 is an FDA 510(k) premarket notification submitted by Argon Medical Devices, Inc. for the device "Halo Single-Loop Microsnare Kit". The FDA issued a decision of Substantially Equivalent on January 5, 2021. The device falls under product code MMX (Device, Percutaneous Retrieval), a Class II device regulated under 21 CFR 870.5150. Argon Medical Devices, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 5, 2021
Date Received
April 10, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Percutaneous Retrieval
Device Class
Class II
Regulation Number
870.5150
Review Panel
CV
Submission Type