The following data is part of a premarket notification filed by Mivi Neuroscience, Inc. with the FDA for Mivi Q Distal Access Catheter.
| Device ID | K212402 |
| 510k Number | K212402 |
| Device Name: | MIVI Q Distal Access Catheter |
| Classification | Catheter, Percutaneous, Neurovasculature |
| Applicant | MIVI Neuroscience, Inc. 6545 City West Parkway Eden Prairie, MN 55443 |
| Contact | Janel Hurtado |
| Correspondent | Janel Hurtado MIVI Neuroscience, Inc. 6545 City West Parkway Eden Prairie, MN 55443 |
| Product Code | QJP |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-08-02 |
| Decision Date | 2021-12-16 |