FDA 510(k) Application Details - K140036

Device Classification Name	More FDA Info for this Device
510(K) Number	K140036
Device Name	APTUS HELI-FX GUIDE - 22CM DEFLECTABLE LENGTH; APTUS HELI-FX GUIDE - 28CM DEFLECTABLE LENGTH; APTUS HELI-FX APPLIER WITH
Applicant	APTUS ENDOSYSTEMS, INC. 271 GIBRALTAR DRIVE SUNNYVALE, CA 94089 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	01/07/2014
Decision Date	02/06/2014
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review