FDA 510(k) Application Details - K192814

Device Classification Name	More FDA Info for this Device
510(K) Number	K192814
Device Name	Pounce Thrombus Retrieval System
Applicant	Surmodics, Inc. 9924 West 74th Street Eden Prairie, MN 55344 US Other 510(k) Applications for this Company
Contact	Amy Yanta 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	10/01/2019
Decision Date	09/21/2020
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