FDA 510(k) Application Details - K183179

Device Classification Name	More FDA Info for this Device
510(K) Number	K183179
Device Name	CAPERE Thrombectomy System
Applicant	Vascular Medcure, Inc. 1500 S. Sunkist St. - Suite H Anaheim, CA 92806 US Other 510(k) Applications for this Company
Contact	Jeffrey P. DuMontelle 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	11/16/2018
Decision Date	02/25/2019
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