510(k) Report

Devices descending from K093965

15 later devices reach Ultraverse 014 and 018 Balloon Dilatation Catheters through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K121856Ultraverse 014 and 018 Pta Balloon Dilatation Catheters Line ExtensionC.R. Bard, Inc.201214—
+2K192318Ultraverse 014 and 018 PTA Balloon Dilatation CathetersBard Peripheral Vascular, Inc.20191—
+2K131199Ultraverse RX Pta Balloon Dilatation CatheterBard Peripheral Vascular, Inc.201311—
+3K223177Highlander™ 014 PTA Balloon Dilatation CatheterC.R. Bard, Inc.20230—
+3K180921Sapphire II PRO Balloon Dilatation CatheterOrbusneich Medical Trading, Inc.20183—
+3K171290Vela RX PTA Balloon Dilatation CatheterCuratia Medical20170—
+3K160013Crosperio OTWKANEKA Corporation20160—
+3K152887Crosperio RX PTA Balloon Dilatation CatheterKANEKA Corporation20160—
+3K150865Metacross RX PTA Balloon Dilitation CatheterKANEKA Corporation20154—
+4K252295RyureiTerumo Corporation20260—
+4K211349Selebrek PTCA Balloon Dilatation CatheterKossel Medtech (Suzhou) Co., Ltd.20220—
+4K200269Sapphire II PROOrbusneich Medical Trading, Inc.20200—
+4K163479R2P Metacross RXKANEKA Corporation20170—
+4K152873Crosstella RX Balloon Dilatation CatheterKANEKA Corporation20161—
+5K201377SABERX RADIANZ Percutaneous Transluminal Angioplasty Dilatation CatheterCordis Corporation20200—