510(k) Report

Devices descending from K103464

9 later devices reach Pacific Xtreme Ptca Balloon Dilatation Catheter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K133843Saber Percutaneous Transluminal Angioplasty Dilatation CatheterCordis Corporation201461
+1K123358Pacific PlusMedtronic Vascular20131—
+2K221245PTA Balloon Dilatation CatheterKossel Medtech (Suzhou) Co., Ltd.20220—
+2K202800Pacific Plus PTA CatheterMedtronic Vascular,Inc (Formerly D.B.A Ev3 Inc.,Covidien, LLC)20200—
+2K151153Pirouette 018Arravasc Limited20154—
+3K173621Advocate PTA CatheterMerit Medical Systems, Inc.20171—
+3K162316Pirouette 014Arravasc, Ltd.20162—
+3K161427Pirouette 035Arravasc Limited20162—
+4K192907Advocate PTA CatheterMerit Medical Systems, Inc.20190—