The following data is part of a premarket notification filed by Mivi Neurovascular, Inc. with the FDA for Merlin Aspiration System.
| Device ID | K213771 |
| 510k Number | K213771 |
| Device Name: | Merlin Aspiration System |
| Classification | Catheter, Embolectomy |
| Applicant | MIVI Neurovascular, Inc. 6545 City West Parkway Eden Prairie, MN 55443 |
| Contact | Janel Hurtado |
| Correspondent | Janel Hurtado MIVI Neurovascular, Inc. 6545 City West Parkway Eden Prairie, MN 55443 |
| Product Code | DXE |
| CFR Regulation Number | 870.5150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-12-02 |
| Decision Date | 2022-01-27 |