FDA 510(k) Application Details - K081697

Device Classification Name	Introducer, Catheter   More FDA Info for this Device
510(K) Number	K081697
Device Name	Introducer, Catheter
Applicant	ACCESS SCIENTIFIC, INC. 12526 HIGH BLUFF DRIVE SUITE 360 SAN DIEGO, CA 92130 US Other 510(k) Applications for this Company
Contact	ALBERT MISAJON 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	06/17/2008
Decision Date	12/04/2008
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