FDA 510(k) Application Details - K092014

Device Classification Name	Introducer, Catheter   More FDA Info for this Device
510(K) Number	K092014
Device Name	Introducer, Catheter
Applicant	ONSET MEDICAL CORPORATION 13900 ALTON PARKWAY, SUITE 120 IRVINE, CA 92618 US Other 510(k) Applications for this Company
Regulation Number	870.1340   More FDA Info for this Regulation Number
Classification Product Code	DYB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/06/2009
Decision Date	10/08/2009
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	Y
Expedited Review