The following data is part of a premarket notification filed by Argon Medical Devices, Inc. with the FDA for Single-loop Snare Retrieval Kit, Triple-loop Snare Retrieval Kit.
| Device ID | K191758 |
| 510k Number | K191758 |
| Device Name: | Single-Loop Snare Retrieval Kit, Triple-Loop Snare Retrieval Kit |
| Classification | Device, Percutaneous Retrieval |
| Applicant | Argon Medical Devices, Inc. 1445 Flat Creek Road Athens, TX 75751 |
| Contact | Jo Huang |
| Correspondent | Jo Huang 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 | 2019-07-01 |
| Decision Date | 2019-12-17 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00886333224616 | K191758 | 000 |
| 00886333224609 | K191758 | 000 |