FDA 510(k) Application Details - DEN100026

Device Classification Name	More FDA Info for this Device
510(K) Number	DEN100026
Device Name	APTUS STEERABLE ENDOGUIDE WITH OBTURATOR, APTUS ENDOSTAPLE APPLIER WITH ENDOSTAPLE CASSETTE, APTUS ENDOSTAPLE CASSETTE
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	12/14/2010
Decision Date	11/21/2011
Decision	DENG -
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status
Type	Post-NSE
Reviewed By Third Party	N
Expedited Review