The following data is part of a premarket notification filed by Mivi Neuroscience, Inc with the FDA for Mivi 6f 25cm Mi-ext Extension Catheter, Mivi 5f 25cm Mi-ext Extension Catheter, Mivi 4f 30cm Mi-ext Extension Catheter, Mivi 3f 43cm Mi-ext Extension Catheter.
| Device ID | K163233 |
| 510k Number | K163233 |
| Device Name: | MIVI 6F 25cm Mi-EXT Extension Catheter, MIVI 5F 25cm Mi-EXT Extension Catheter, MIVI 4F 30cm Mi-EXT Extension Catheter, MIVI 3F 43cm Mi-EXT Extension Catheter |
| Classification | Catheter, Percutaneous |
| Applicant | MIVI NEUROSCIENCE, INC 6545 City West Parkway Eden Prairie, MN 55344 |
| Contact | Randy Labounty |
| Correspondent | Avi Roop PHILBROOK CORPORATION 8701 E. VISTA BONITA DR., SUITE 210 Scottsdale, AZ 85255 |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-11-17 |
| Decision Date | 2017-04-06 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B293Q6691450 | K163233 | 000 |
| B293Q5571450 | K163233 | 000 |
| B293Q4431500 | K163233 | 000 |
| B293Q3361630 | K163233 | 000 |
| B293MIEXT6925U0 | K163233 | 000 |
| B293MIEXT69250 | K163233 | 000 |
| B293MIEXT57250 | K163233 | 000 |
| B293MIEXT43300 | K163233 | 000 |
| B293MIEXT36370 | K163233 | 000 |