The following data is part of a premarket notification filed by Angiodynamics, Inc. with the FDA for Alphavac Multipurpose Mechanical Aspiration (mma) System.
| Device ID | K211081 |
| 510k Number | K211081 |
| Device Name: | AlphaVac Multipurpose Mechanical Aspiration (MMA) 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 | 2021-04-12 |
| Decision Date | 2021-06-04 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15051684025942 | K211081 | 000 |
| 15051684025959 | K211081 | 000 |
| H787253010 | K211081 | 000 |
| H787253000 | K211081 | 000 |