510(k) K200268
K200268 is an FDA 510(k) premarket notification submitted by Argon Medical Devices, Inc. for the device "Halo Single-Loop Snare Kit". The FDA issued a decision of Substantially Equivalent on June 3, 2020. 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
- June 3, 2020
- Date Received
- February 3, 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