510(k) K163233

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 by Mivi Neuroscience, Inc. — Product Code DQY

K163233 is an FDA 510(k) premarket notification submitted by Mivi Neuroscience, Inc. for the device "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". The FDA issued a decision of Substantially Equivalent on April 6, 2017. The device falls under product code DQY (Catheter, Percutaneous), a Class II device regulated under 21 CFR 870.1250. Mivi Neuroscience, Inc. has at least 4 other 510(k) clearances on record.