The following data is part of a premarket notification filed by Mivi Neurovascular with the FDA for Q3 Distal Access Catheter, Q4 Distal Access Catheter, Q5 Distal Access Catheter, Q6distal Access Catheter.
| Device ID | K192558 |
| 510k Number | K192558 |
| Device Name: | Q3 Distal Access Catheter, Q4 Distal Access Catheter, Q5 Distal Access Catheter, Q6Distal Access Catheter |
| Classification | Catheter, Percutaneous |
| Applicant | MIVI Neurovascular 6545 City West Parkway Eden Prairie, MN 55344 |
| Contact | Janel Hurtado |
| Correspondent | Janel Hurtado MIVI Neurovascular 6545 City West Parkway Eden Prairie, MN 55344 |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-09-17 |
| Decision Date | 2020-04-06 |