Halo Single-Loop Snare Kit— 510(k) K200268
Substantially EquivalentArgon 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.. Device class: 2.
Clearance details
- Applicant
- Argon Medical Devices, Inc.
- Product code
- Code MMX
- Device class
- Class 2
- Regulation
- 21 CFR 870.5150
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- 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, through . 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.