510(k) Report

Devices descending from K103751

15 later devices reach Mustang Balloon Dilatation Catheters through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K231402HP PTA Balloon Dilatation CatheterKossel Medtech (Suzhou) Co., Ltd.20230—
+1K214009D·Kaptain PTA High Pressure Balloon Dilatation CatheterDk Medical Technology Co., Ltd.20230—
+1K212215Tiche PTA Balloon Dilatation CatheterBrosmed Medical Co., Ltd.20220—
+1K201170Athletis PTA Balloon Dilatation CatheterBoston Scientific Corporation20201—
+1K172033Pirouette High Pressure (HP)Arravasc, Ltd.20170—
+1K160941Castor, Achilles and Hermes NC PTA Balloon Dilatation CatheterBrosmed Medical Co., Ltd.201601
+1K160256Polux , Minerva and Atropos PTA Balloon Dilatation CatheterBrosmed Medical Co., Ltd.20161—
+1K142654Fortrex 0.035 OTW PTA Balloon CatheterCovidien, LLC20140—
+1K113681Gladiator Pta Balloon Dilation CatheterBoston Scientific20122—
+1K112697Charger Pta Ballon Dilatation CatheterBoston Scientific20111—
+2K260416ZYLOX Hippo PTA Balloon Dilatation CatheterZylox Medtech Co., Ltd.20260—
+2K243704Parafleet SC 014 PTA Balloon Dilatation Catheter; Parafleet SC 018 PTA Balloon…Brosmed Medical Co., Ltd.20250—
+2K220410Ebony HP PTA OTW 0.035 CatheterNatec Medical, Ltd.20220—
+2K132810Gladiator Elite Pta Balloon Dilatation CatheterBoston Scientific Corp20141—
+3K141597Mustang Balloon Dialation CatheterBoston Scientific Corporation20140—