510(k) Report

Devices descending from K103322

6 later devices reach Evercross 0.035 Otw Pta Dilation Catheter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K142654Fortrex 0.035 OTW PTA Balloon CatheterCovidien, LLC20140—
+1K110319Evercross 0.035 Otw Pta Dilatation CatheterEv3, Inc.20115—
+2K190753EverCrossTM 0.035 OTW PTA Dilatation CatheterMedtronic, Inc. (Formerly D.B.A. Ev3, Inc. Covidien, LLC.)20190—
+2K151141Cronus HP - High Pressure Peripheral Balloon CatheterNipro Medical Corporation20161—
+2K111899Armada 35/35LL Pta CatheterAbbott Vascular201101
+3K190037Cronus HP PTA Balloon CatheterNipro Medical Corporation20190—