FDA 510(k) Application Details - K213166

Device Classification Name	More FDA Info for this Device
510(K) Number	K213166
Device Name	Thrombuster II Aspiration Catheter
Applicant	Kaneka Medical America LLC 623 Fifth Avenue New York, NY 10022 US Other 510(k) Applications for this Company
Contact	Audra Bogucki Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QEZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/28/2021
Decision Date	10/26/2021
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review