The following data is part of a premarket notification filed by Angiodynamics, Inc. with the FDA for Alphavac Multipurpose Mechanical Aspiration (mma) F1885 System.
| Device ID | K213388 |
| 510k Number | K213388 |
| Device Name: | AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 System |
| Classification | Aspiration Thrombectomy Catheter |
| Applicant | AngioDynamics, Inc. 603 Queensbury Ave Queensbury, NY 12804 |
| Contact | Kasey E. Newcomb |
| Correspondent | Kasey E. Newcomb AngioDynamics, Inc. 603 Queensbury Ave Queensbury, NY 12804 |
| Product Code | QEZ |
| CFR Regulation Number | 870.5150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-10-14 |
| Decision Date | 2022-04-04 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15051684025966 | K213388 | 000 |