FDA 510(k) Applications for Medical Device Product Code: OTD ()

FDA 510(k) Applications for Medical Device Product Code "OTD"

FDA 510(k) Number	Applicant	Device Name	Decision Date
K141041	APTUS ENDOSYSTEMS	APTUS HELI-FX ANCILLARY ENDOANCHOR CASSETTE	05/16/2014
K121168	APTUS ENDOSYSTEMS, INC.	APTUS 18FR HELIFX GUIDE-22 DEFLECTABLE LENGTH	08/08/2012
K130677	APTUS ENDOSYSTEMS, INC.	APTUS HELI-FX AORTIC SECUREMENT SYSTEM	04/12/2013
K140036	APTUS ENDOSYSTEMS, INC.	APTUS HELI-FX GUIDE - 22CM DEFLECTABLE LENGTH; APTUS HELI-FX GUIDE - 28CM DEFLECTABLE LENGTH; APTUS HELI-FX APPLIER WITH	02/06/2014
DEN100026	APTUS ENDOSYSTEMS, INC.	APTUS STEERABLE ENDOGUIDE WITH OBTURATOR, APTUS ENDOSTAPLE APPLIER WITH ENDOSTAPLE CASSETTE, APTUS ENDOSTAPLE CASSETTE	11/21/2011
K171427	Medtronic Vascular, Inc.	Heli-FX Applier, Heli-FX Guide, Ancillary EndoAnchor Cassette	06/13/2017
K182957	Medtronic Vascular, Inc.	Heli-FX EndoAnchor System	11/21/2018