K223176 is an FDA 510(k) clearance for the Cleaner Plus™ Thrombectomy System, Cleaner Plus™ Aspiration Catheter, Cleaner Plus™ Handpiece with 65cm Maceration Wire, Cleaner Plus™ Handpiece with 135cm Maceration Wire, Cleaner Plus™ Aspiration Canister. This device is classified as a Catheter, Continuous Flush (Class II - Special Controls, product code KRA).
Submitted by Argon Medical Devices, Inc. (Athens, US). The FDA issued a Cleared decision on April 10, 2023, 181 days after receiving the submission on October 11, 2022.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1210.
| 510(k) Number | K223176 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 11, 2022 |
| Decision Date | April 10, 2023 |
| Days to Decision | 181 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | KRA — Catheter, Continuous Flush |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1210 |