FDA 510(k) Application Details - K201518

Device Classification Name	More FDA Info for this Device
510(K) Number	K201518
Device Name	Route 92 Medical 088 Access System
Applicant	Route 92 Medical 155 Bovet Road, Suite 100 San Mateo, CA 94402 US Other 510(k) Applications for this Company
Contact	Kathy Tansey Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QJP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/08/2020
Decision Date	08/14/2020
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review