Submission Details
| 510(k) Number | K211798 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | June 10, 2021 |
| Decision Date | February 24, 2022 |
| Days to Decision | 259 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
Cleared
Traditional
Cleaner Plus Thrombectomy System
Feb 2022
Decision
259d
Days
Class 2
Risk
About This 510(k) Submission
K211798 is an FDA 510(k) clearance for the Cleaner Plus Thrombectomy System, a Peripheral Mechanical Thrombectomy With Aspiration (Class II — Special Controls, product code QEW), submitted by Argon Medical Devices, Inc. (Athens, US). The FDA issued a Cleared decision on February 24, 2022, 259 days after receiving the submission on June 10, 2021. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.5150.
Device Classification
| Product Code | QEW — Peripheral Mechanical Thrombectomy With Aspiration |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 870.5150 |
| Definition | To Mechanically Disrupt Thrombus And/or Debris Prior To Removal From The Peripheral Vasculature Through Aspiration. |
Manufacturer
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