The following data is part of a premarket notification filed by Argon Medical Devices, Inc. with the FDA for Halo Single-loop Microsnare Kit.
| Device ID | K200963 |
| 510k Number | K200963 |
| Device Name: | Halo Single-Loop Microsnare Kit |
| Classification | Device, Percutaneous Retrieval |
| Applicant | Argon Medical Devices, Inc. 1445 Flat Creek Road Athens, TX 75751 |
| Contact | Ana Jimenez-hughes |
| Correspondent | Ana Jimenez-hughes Argon Medical Devices, Inc. 1445 Flat Creek Road Athens, TX 75751 |
| Product Code | MMX |
| CFR Regulation Number | 870.5150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-04-10 |
| Decision Date | 2021-01-05 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00886333224845 | K200963 | 000 |
| 00886333224838 | K200963 | 000 |
| 00886333224821 | K200963 | 000 |
| 00886333224814 | K200963 | 000 |
| 00886333224807 | K200963 | 000 |
| 00886333224791 | K200963 | 000 |