FDA 510(k) Application Details - K220501

Device Classification Name	More FDA Info for this Device
510(K) Number	K220501
Device Name	Pounce Thrombectomy System
Applicant	Surmodics Inc. 7905 Golden Triangle Drive Suite 190 Eden Prairie, MN 55344 US Other 510(k) Applications for this Company
Contact	Holly Ramirez 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	02/22/2022
Decision Date	03/23/2022
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