510(k) Report

Devices descending from K131199

11 later devices reach Ultraverse RX Pta Balloon Dilatation Catheter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K180921Sapphire II PRO Balloon Dilatation CatheterOrbusneich Medical Trading, Inc.20183—
+1K171290Vela RX PTA Balloon Dilatation CatheterCuratia Medical20170—
+1K160013Crosperio OTWKANEKA Corporation20160—
+1K152887Crosperio RX PTA Balloon Dilatation CatheterKANEKA Corporation20160—
+1K150865Metacross RX PTA Balloon Dilitation CatheterKANEKA Corporation20154—
+2K252295RyureiTerumo Corporation20260—
+2K211349Selebrek PTCA Balloon Dilatation CatheterKossel Medtech (Suzhou) Co., Ltd.20220—
+2K200269Sapphire II PROOrbusneich Medical Trading, Inc.20200—
+2K163479R2P Metacross RXKANEKA Corporation20170—
+2K152873Crosstella RX Balloon Dilatation CatheterKANEKA Corporation20161—
+3K201377SABERX RADIANZ Percutaneous Transluminal Angioplasty Dilatation CatheterCordis Corporation20200—