Halo Single-Loop Snare Kit— 510(k) K200268

Substantially Equivalent

Argon Medical Devices, Inc.

FDA 510(k) clearance K200268 for Halo Single-Loop Snare Kit, Substantially Equivalent on 2020-06-03. Applicant: Argon Medical Devices, Inc..

Clearance details

Applicant: Argon Medical Devices, Inc.
Product code: Code MMX
Advisory panel: Cardiovascular
Date received: 2020-02-03
Decision date: 2020-06-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Athens, TX, US

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Adverse events under product code MMX

product code MMX

Death: 3
Total: 3

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.