The following data is part of a premarket notification filed by Mivi Neuroscience, Inc with the FDA for Mivi Mi-axus Guide Catheter.
| Device ID | K151396 |
| 510k Number | K151396 |
| Device Name: | MIVI Mi-AXUS Guide Catheter |
| Classification | Catheter, Percutaneous |
| Applicant | MIVI NEUROSCIENCE, INC 6545 City West Parkway Eden Prairie, MN 55344 |
| Contact | Matthew Ogle |
| Correspondent | Randy Labounty NovaQual 180S. 600W. Logan, UT 84321 Logan, UT 84321 |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-05-26 |
| Decision Date | 2015-12-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B293MIA9095S0 | K151396 | 000 |
| B293MIA9090S0 | K151396 | 000 |
| B293MIA90900 | K151396 | 000 |
| B293MIA9080S0 | K151396 | 000 |
| B293MIA90800 | K151396 | 000 |