FDA 510(k) Application Details - K191606

Device Classification Name	Catheter, Intravascular Occluding, Temporary   More FDA Info for this Device
510(K) Number	K191606
Device Name	Catheter, Intravascular Occluding, Temporary
Applicant	RenovoRx, Inc. 4546 El Camino Real, Suite 223 Los Altos, CA 94022 US Other 510(k) Applications for this Company
Contact	Kamran Najmabadi Other 510(k) Applications for this Contact
Regulation Number	870.4450   More FDA Info for this Regulation Number
Classification Product Code	MJN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/17/2019
Decision Date	08/07/2019
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