FDA 510(k) Application Details - K220780

Device Classification Name	More FDA Info for this Device
510(K) Number	K220780
Device Name	ROVO Mechanical Thrombectomy Device
Applicant	2MG, Inc 176 N Nanagosa Suttons Bay, MI 49682 US Other 510(k) Applications for this Company
Contact	Ted Karmon Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QEW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/17/2022
Decision Date	03/31/2023
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