510(k) Report

Devices descending from K112797

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K121442Powerflex Pro Percutaneous Transluminal Angioplasty CatheterCordis Corporation201292
+2K201333SABER .035 PTA Dilatation CatheterCordis Corporation20201—
+2K133843Saber Percutaneous Transluminal Angioplasty Dilatation CatheterCordis Corporation201461
+3K221245PTA Balloon Dilatation CatheterKossel Medtech (Suzhou) Co., Ltd.20220—
+3K210626SABER .035 Percutaneous Transluminal Angioplasty (PTA) Dilatation CatheterCordis Corporation20210—
+3K151153Pirouette 018Arravasc Limited20154—
+4K173621Advocate PTA CatheterMerit Medical Systems, Inc.20171—
+4K162316Pirouette 014Arravasc, Ltd.20162—
+4K161427Pirouette 035Arravasc Limited20162—
+5K192907Advocate PTA CatheterMerit Medical Systems, Inc.20190—