FDA 510(k) Application Details - K090918

Device Classification Name	Catheter, Percutaneous   More FDA Info for this Device
510(K) Number	K090918
Device Name	Catheter, Percutaneous
Applicant	NFOCUS NEUROMEDICAL, INC. 2191 E. BAYSHORE ROAD SUITE 100 PALO ALTO, CA 94303 US Other 510(k) Applications for this Company
Contact	BOB FOUNDS Other 510(k) Applications for this Contact
Regulation Number	870.1250   More FDA Info for this Regulation Number
Classification Product Code	DQY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/01/2009
Decision Date	07/30/2009
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