FDA 510(k) Application Details - K202049

Device Classification Name	Catheter, Embolectomy   More FDA Info for this Device
510(K) Number	K202049
Device Name	Catheter, Embolectomy
Applicant	Applied Medical Resources Corporation 22872 Avenida Empresa Rancho Santa Margarita, CA 92688 US Other 510(k) Applications for this Company
Contact	Andrew Powers Davis Other 510(k) Applications for this Contact
Regulation Number	870.5150   More FDA Info for this Regulation Number
Classification Product Code	DXE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/24/2020
Decision Date	09/07/2021
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