Submission Details
| 510(k) Number | K211081 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | April 12, 2021 |
| Decision Date | June 04, 2021 |
| Days to Decision | 53 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
Cleared
Traditional
AlphaVac Multipurpose Mechanical Aspiration (MMA) System
Jun 2021
Decision
53d
Days
Class 2
Risk
About This 510(k) Submission
K211081 is an FDA 510(k) clearance for the AlphaVac Multipurpose Mechanical Aspiration (MMA) 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 June 4, 2021, 53 days after receiving the submission on April 12, 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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