510(k) Report

Devices descending from K100490

12 later devices reach Litepac, Model 682 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K131199Ultraverse RX Pta Balloon Dilatation CatheterBard Peripheral Vascular, Inc.201311—
+2K180921Sapphire II PRO Balloon Dilatation CatheterOrbusneich Medical Trading, Inc.20183—
+2K171290Vela RX PTA Balloon Dilatation CatheterCuratia Medical20170—
+2K160013Crosperio OTWKANEKA Corporation20160—
+2K152887Crosperio RX PTA Balloon Dilatation CatheterKANEKA Corporation20160—
+2K150865Metacross RX PTA Balloon Dilitation CatheterKANEKA Corporation20154—
+3K252295RyureiTerumo Corporation20260—
+3K211349Selebrek PTCA Balloon Dilatation CatheterKossel Medtech (Suzhou) Co., Ltd.20220—
+3K200269Sapphire II PROOrbusneich Medical Trading, Inc.20200—
+3K163479R2P Metacross RXKANEKA Corporation20170—
+3K152873Crosstella RX Balloon Dilatation CatheterKANEKA Corporation20161—
+4K201377SABERX RADIANZ Percutaneous Transluminal Angioplasty Dilatation CatheterCordis Corporation20200—