510(k) Report

Devices descending from K121442

9 later devices reach Powerflex Pro Percutaneous Transluminal Angioplasty Catheter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K201333SABER .035 PTA Dilatation CatheterCordis Corporation20201—
+1K133843Saber Percutaneous Transluminal Angioplasty Dilatation CatheterCordis Corporation201461
+2K221245PTA Balloon Dilatation CatheterKossel Medtech (Suzhou) Co., Ltd.20220—
+2K210626SABER .035 Percutaneous Transluminal Angioplasty (PTA) Dilatation CatheterCordis Corporation20210—
+2K151153Pirouette 018Arravasc Limited20154—
+3K173621Advocate PTA CatheterMerit Medical Systems, Inc.20171—
+3K162316Pirouette 014Arravasc, Ltd.20162—
+3K161427Pirouette 035Arravasc Limited20162—
+4K192907Advocate PTA CatheterMerit Medical Systems, Inc.20190—