K163233 is an FDA 510(k) clearance for the 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. This device is classified as a Catheter, Percutaneous (Class II - Special Controls, product code DQY).
Submitted by Mivi Neuroscience, Inc. (Eden Prarie, US). The FDA issued a Cleared decision on April 6, 2017, 140 days after receiving the submission on November 17, 2016.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1250.
| 510(k) Number | K163233 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 17, 2016 |
| Decision Date | April 06, 2017 |
| Days to Decision | 140 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Statement |
| Product Code | DQY - Catheter, Percutaneous |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1250 |