K232443 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 September 7, 2023, 24 days after receiving the submission on August 14, 2023.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.5150.
| 510(k) Number | K232443 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 14, 2023 |
| Decision Date | September 07, 2023 |
| Days to Decision | 24 days |
| Submission Type | Special |
| 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 |