FDA 510(k) Application Details - K121168

Device Classification Name	More FDA Info for this Device
510(K) Number	K121168
Device Name	APTUS 18FR HELIFX GUIDE-22 DEFLECTABLE LENGTH
Applicant	APTUS ENDOSYSTEMS, INC. 777 N. PASTORIA AVE. SUNNYVALE, CA 94085 US Other 510(k) Applications for this Company
Contact	BURT GOODSON Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OTD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/17/2012
Decision Date	08/08/2012
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