510(k) Report

Devices descending from K100921

12 later devices reach Admiral Xtreme Pta Balloon Dilatation Catheter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K173515Admiral XtremeMedtronic Vascular20180—
+1K111899Armada 35/35LL Pta CatheterAbbott Vascular201101
+1K103464Pacific Xtreme Ptca Balloon Dilatation CatheterMedtronic, Inc.201091
+2K133843Saber Percutaneous Transluminal Angioplasty Dilatation CatheterCordis Corporation201461
+2K123358Pacific PlusMedtronic Vascular20131—
+3K221245PTA Balloon Dilatation CatheterKossel Medtech (Suzhou) Co., Ltd.20220—
+3K202800Pacific Plus PTA CatheterMedtronic Vascular,Inc (Formerly D.B.A Ev3 Inc.,Covidien, LLC)20200—
+3K151153Pirouette 018Arravasc Limited20154—
+4K173621Advocate PTA CatheterMerit Medical Systems, Inc.20171—
+4K162316Pirouette 014Arravasc, Ltd.20162—
+4K161427Pirouette 035Arravasc Limited20162—
+5K192907Advocate PTA CatheterMerit Medical Systems, Inc.20190—