FDA 510(k) Application Details - K984258

Device Classification Name	Catheter, Intravascular, Diagnostic   More FDA Info for this Device
510(K) Number	K984258
Device Name	Catheter, Intravascular, Diagnostic
Applicant	NEURO VASX, INC. 2355 POLARIS LN. NORTH SUITE 116 PLYMOUTH, MN 55447 US Other 510(k) Applications for this Company
Contact	JEFFREY A LEE Other 510(k) Applications for this Contact
Regulation Number	870.1200   More FDA Info for this Regulation Number
Classification Product Code	DQO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/30/1998
Decision Date	02/11/1999
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