Submission Details
| 510(k) Number | K213388 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | October 14, 2021 |
| Decision Date | April 04, 2022 |
| Days to Decision | 172 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
Cleared
Traditional
AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 System
Apr 2022
Decision
172d
Days
Class 2
Risk
About This 510(k) Submission
K213388 is an FDA 510(k) clearance for the AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 System, a Aspiration Thrombectomy Catheter (Class II — Special Controls, product code QEZ), submitted by AngioDynamics, Inc. (Queensburgy, US). The FDA issued a Cleared decision on April 4, 2022, 172 days after receiving the submission on October 14, 2021. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.5150.
Device Classification
| Product Code | QEZ — Aspiration Thrombectomy Catheter |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 870.5150 |
| Definition | To Remove Thrombus From The Peripheral And/or Coronary Vasculature Through Aspiration. |
Manufacturer
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