FDA 510(k) Application Details - K213771

Device Classification Name	Catheter, Embolectomy   More FDA Info for this Device
510(K) Number	K213771
Device Name	Catheter, Embolectomy
Applicant	MIVI Neurovascular, Inc. 6545 City West Parkway Eden Prairie, MN 55443 US Other 510(k) Applications for this Company
Contact	Janel Hurtado Other 510(k) Applications for this Contact
Regulation Number	870.5150   More FDA Info for this Regulation Number
Classification Product Code	DXE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/02/2021
Decision Date	01/27/2022
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review