510(k) Report

Devices descending from K032737

17 later devices reach Cordis Powerflex Extreme Pta Balloon Catheter, Cordis Powerflex Plus Pta… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K112797Powerflex Pro Percutaneous Transluminal Angioplasty CatheterCordis Corp.201210—
+1K092361Reef HP 0.035 Otw Pta Balloon Dilatation CatheterInvatec S.P.A.20093—
+1K082646Optimus 0.035 Pta Balloon Dilatation CatheterUsci Ireland20080—
+1K072156Optimus 0.035 Inch Pta Balloon Dilatation CatheterUsci Ireland20071—
+2K123358Pacific PlusMedtronic Vascular20131—
+2K121442Powerflex Pro Percutaneous Transluminal Angioplasty CatheterCordis Corporation201292
+2K121265Amphirion Plus Pta CatheterMedtronic, Inc.20120—
+3K202800Pacific Plus PTA CatheterMedtronic Vascular,Inc (Formerly D.B.A Ev3 Inc.,Covidien, LLC)20200—
+3K201333SABER .035 PTA Dilatation CatheterCordis Corporation20201—
+3K133843Saber Percutaneous Transluminal Angioplasty Dilatation CatheterCordis Corporation201461
+4K221245PTA Balloon Dilatation CatheterKossel Medtech (Suzhou) Co., Ltd.20220—
+4K210626SABER .035 Percutaneous Transluminal Angioplasty (PTA) Dilatation CatheterCordis Corporation20210—
+4K151153Pirouette 018Arravasc Limited20154—
+5K173621Advocate PTA CatheterMerit Medical Systems, Inc.20171—
+5K162316Pirouette 014Arravasc, Ltd.20162—
+5K161427Pirouette 035Arravasc Limited20162—
+6K192907Advocate PTA CatheterMerit Medical Systems, Inc.20190—