FDA 510(k) Application Details - K042308

Device Classification Name	Introducer, Catheter   More FDA Info for this Device
510(K) Number	K042308
Device Name	Introducer, Catheter
Applicant	FACILE MEDICAL, INC. 27001 LA PAZ SUITE 312 MISSION VIEJO, CA 92691 US Other 510(k) Applications for this Company
Contact	ALBERT REGO Other 510(k) Applications for this Contact
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	08/25/2004
Decision Date	02/17/2005
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