FDA 510(k) Application Details - K201705

Device Classification Name	More FDA Info for this Device
510(K) Number	K201705
Device Name	ReVene Thrombectomy Catheter
Applicant	Vetex Medical, Ltd. Business Innovation Center, NUI Galway Newcastle Road Galway IE Other 510(k) Applications for this Company
Contact	Mark Bruzzi 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	06/22/2020
Decision Date	12/22/2020
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