510(k) Report

Devices descending from K110319

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

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