K191758 is an FDA 510(k) clearance for the Single-Loop Snare Retrieval Kit, Triple-Loop Snare Retrieval Kit. This device is classified as a Device, Percutaneous Retrieval (Class II - Special Controls, product code MMX).
Submitted by Argon Medical Devices, Inc. (Athens, US). The FDA issued a Cleared decision on December 17, 2019, 169 days after receiving the submission on July 1, 2019.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.5150.
| 510(k) Number | K191758 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 01, 2019 |
| Decision Date | December 17, 2019 |
| Days to Decision | 169 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | MMX — Device, Percutaneous Retrieval |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.5150 |