510(k) Report

Devices descending from K993305

16 later devices reach Transluminal Balloon Dilatation Catheter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K103751Mustang Balloon Dilatation CathetersBoston Scientific201115—
+2K231402HP PTA Balloon Dilatation CatheterKossel Medtech (Suzhou) Co., Ltd.20230—
+2K214009D·Kaptain PTA High Pressure Balloon Dilatation CatheterDk Medical Technology Co., Ltd.20230—
+2K212215Tiche PTA Balloon Dilatation CatheterBrosmed Medical Co., Ltd.20220—
+2K201170Athletis PTA Balloon Dilatation CatheterBoston Scientific Corporation20201—
+2K172033Pirouette High Pressure (HP)Arravasc, Ltd.20170—
+2K160941Castor, Achilles and Hermes NC PTA Balloon Dilatation CatheterBrosmed Medical Co., Ltd.201601
+2K160256Polux , Minerva and Atropos PTA Balloon Dilatation CatheterBrosmed Medical Co., Ltd.20161—
+2K142654Fortrex 0.035 OTW PTA Balloon CatheterCovidien, LLC20140—
+2K113681Gladiator Pta Balloon Dilation CatheterBoston Scientific20122—
+2K112697Charger Pta Ballon Dilatation CatheterBoston Scientific20111—
+3K260416ZYLOX Hippo PTA Balloon Dilatation CatheterZylox Medtech Co., Ltd.20260—
+3K243704Parafleet SC 014 PTA Balloon Dilatation Catheter; Parafleet SC 018 PTA Balloon…Brosmed Medical Co., Ltd.20250—
+3K220410Ebony HP PTA OTW 0.035 CatheterNatec Medical, Ltd.20220—
+3K132810Gladiator Elite Pta Balloon Dilatation CatheterBoston Scientific Corp20141—
+4K141597Mustang Balloon Dialation CatheterBoston Scientific Corporation20140—