FDA 510(k) Application Details - K241362

Device Classification Name	More FDA Info for this Device
510(K) Number	K241362
Device Name	Pounce XL Thrombectomy System (PTS-1011-7F135)
Applicant	Surmodics Inc. 7905 Golden Triangle Dr. Ste. 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	05/14/2024
Decision Date	09/11/2024
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