# K200963: Halo Single-Loop Microsnare Kit

- Pathway: 510(k) (Traditional)
- Applicant: Argon Medical Devices, Inc.
- Decided: Jan 5, 2021 after 270 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 K914067 (1991). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K970668: The Amplantz Goose Neck Microsnare, Microvena Corp. (1998) Summary page 4.

## Indications for use
The Halo™ Single-Loop Microsnare Kit is intended for use in the retrieval and manipulation of atraumatic foreign bodies located in the coronary and peripheral cardiovascular system and the extra-cranial neurovascular anatomy.

Source page: https://510kreport.com/device/K200963
Methodology: https://510kreport.com/methodology