FDA 510(k) Application Details - K100135

Device Classification Name	Catheter, Percutaneous   More FDA Info for this Device
510(K) Number	K100135
Device Name	Catheter, Percutaneous
Applicant	GUIDED DELIVERY SYSTEMS 2355 CALLE DE LUNA SANTA CLARA, CA 95054 US Other 510(k) Applications for this Company
Contact	BONNIE L MCINERNEY 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	01/19/2010
Decision Date	04/16/2010
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