FDA 510(k) Application Details - K151825

Device Classification Name	Guide, Wire, Catheter, Neurovasculature   More FDA Info for this Device
510(K) Number	K151825
Device Name	Guide, Wire, Catheter, Neurovasculature
Applicant	MIVI NEUROSCIENCE, INC. 6545 CITY WEST PARKWAY EDEN PRAIRIE, MN 55344 US Other 510(k) Applications for this Company
Contact	RANDY LABOUNTY Other 510(k) Applications for this Contact
Regulation Number	870.1330   More FDA Info for this Regulation Number
Classification Product Code	MOF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/06/2015
Decision Date	11/16/2015
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review