# K200268: Halo™ Single-Loop Snare Kit

- Pathway: 510(k) (Traditional)
- Applicant: Argon Medical Devices, Inc.
- Decided: Jun 3, 2020 after 121 days
- Product code: MMX (Device, Percutaneous Retrieval)
- Device class: 2
- Regulation: 21 CFR 870.5150
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K901502 (1990). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K972511: Amplatz Goose Neck Snare Kit/ Catheter, Microvena Corp. (1998) Summary page 4.

## Indications for use
The Halo™ Single-Loop Snare Kit is intended for use in the cardiovascular system or hollow viscous to retrieve and manipulate foreign objects.

Source page: https://510kreport.com/device/K200268
Methodology: https://510kreport.com/methodology