FDA 510(k) Application Details - K163233

Device Classification Name	Catheter, Percutaneous   More FDA Info for this Device
510(K) Number	K163233
Device Name	Catheter, Percutaneous
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	870.1250   More FDA Info for this Regulation Number
Classification Product Code	DQY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/17/2016
Decision Date	04/06/2017
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review