FDA 510(k) Application Details - K123605

Device Classification Name	Catheter, Ventricular   More FDA Info for this Device
510(K) Number	K123605
Device Name	Catheter, Ventricular
Applicant	MRI INTERVENTIONS, INC. 5 MUSICK IRVINE, CA 92618 US Other 510(k) Applications for this Company
Contact	EDWARD F WADDELL Other 510(k) Applications for this Contact
Regulation Number	882.4100   More FDA Info for this Regulation Number
Classification Product Code	HCA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/21/2012
Decision Date	08/16/2013
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	NE - Neurology
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review