The following data is part of a premarket notification filed by Mivi Neuroscience, Inc. with the FDA for Viradius Neurowire.
| Device ID | K151825 |
| 510k Number | K151825 |
| Device Name: | Viradius Neurowire |
| Classification | Guide, Wire, Catheter, Neurovasculature |
| Applicant | MIVI NEUROSCIENCE, INC. 6545 CITY WEST PARKWAY Eden Prairie, MN 55344 |
| Contact | Randy Labounty |
| Correspondent | Randy Labounty MIVI NEUROSCIENCE, INC. 6545 CITY WEST PARKWAY Eden Prairie, MN 55344 |
| Product Code | MOF |
| CFR Regulation Number | 870.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-07-06 |
| Decision Date | 2015-11-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B293VR014300G0 | K151825 | 000 |
| B293VR014205G0 | K151825 | 000 |