510(k) Report

Devices descending from K112994

15 later devices reach Cre Ditatation Ballon through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K253987BARE Wireguided Balloon Dilation Catheter (1235)GIE Medical20260—
+1K241888Single-use Balloon Dilatation CatheterLeo Medical Co., Ltd.20240—
+1K232245VedDilator ^TM (3-Stage Balloon Dilation Catheter)Jiangsu Vedkang Medical Science and Technology Co., Ltd.20240—
+1K222663MultiStage Balloon Dilatation CatheterDongguan TT Medical, Inc.20230—
+1K180086Gyrus ACMI – EZDilate 3-Stage Balloon Dilatation CatheterGyrus Acmi, Inc.2018013
+1K172520CRE RX Biliary Balloon Dilatation CatheterBoston Scientific Corporation20171—
+1K151925Elation Wireguided Balloon Dilation CatheterMerit Medical Systems, Inc.20150—
+1K151671Disposable Multistage Dilation Balloon CatheterMicro-Tech (Nanjing) Co., Ltd.20154—
+1K150142Single Use Balloon Dilator V (with Knife)Olympus Medical Systems Corp.20151—
+1K143609Gyrus ACMI - EZDilate 3-Stage Balloon Dilatation CatheterOlympus Surgical Technologies America20151—
+2K193039Single Use Balloon Dilator V (with knife)Olympus Medical Systems Corp.20190—
+2K162226Reliant Multistage Dilatation Balloon CatheterMicro-Tech (Nanjing) Co., Ltd.20173—
+3K180418Reliant (TM) Multistage Dilatation Balloon CatheterMicro-Tech (Nanjing) Co., Ltd.20182—
+4K253393Single-use Balloon Dilatation Catheter (AG-5251-083018 AG-5251-085518 AG-5251-088018…Hangzhou AGS MedTech Co., Ltd.20260—
+4K253832Dilation Balloon CatheterMirco-Tech (Nanjing) Co., Ltd.20260—