FDA 510(k) Application Details - K150108

Device Classification Name	Device, Vascular, For Promoting Embolization   More FDA Info for this Device
510(K) Number	K150108
Device Name	Device, Vascular, For Promoting Embolization
Applicant	REVERSE MEDICAL CORPORATION 13700 ALTON PARKWAY, SUITE 167 IRVINE, CA 92618 US Other 510(k) Applications for this Company
Contact	LAURA HEATON Other 510(k) Applications for this Contact
Regulation Number	870.3300   More FDA Info for this Regulation Number
Classification Product Code	KRD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/20/2015
Decision Date	04/22/2015
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