FDA 510(k) Application Details - K192558

Device Classification Name	Catheter, Percutaneous   More FDA Info for this Device
510(K) Number	K192558
Device Name	Catheter, Percutaneous
Applicant	MIVI Neurovascular 6545 City West Parkway Eden Prairie, MN 55344 US Other 510(k) Applications for this Company
Contact	Janel Hurtado 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	09/17/2019
Decision Date	04/06/2020
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