510(k) Report

Devices descending from DEN100026

6 later devices reach Aptus Steerable Endoguide with Obturator, Aptus Endostaple Applier with… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K171427Heli-FX Applier, Heli-FX Guide, Ancillary EndoAnchor CassetteMedtronic Vascular, Inc.201711
+1K141041Aptus Heli-FX Ancillary Endoanchor CassetteAptus Endosystems20142—
+1K140036Aptus Heli-FX Guide - 22CM Deflectable Length; Aptus Heli-FX Guide - 28CM Deflectable…Aptus Endosystems, Inc.20143—
+1K130677Aptus Heli-FX Aortic Securement SystemAptus Endosystems, Inc.20134—
+1K121168Aptus 18FR Helifx Guide-22 Deflectable LengthAptus Endosystems, Inc.20125—
+2K182957Heli-FX EndoAnchor SystemMedtronic Vascular, Inc.20180—