510(k) Report

Devices descending from K974788

19 later devices reach Cre (TM) Balloon Dilatation Catheter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K110833Cre Balloon Dilatation CatheterBoston Scientific Corporation2011176
+1K010714Expander, Models 1400880, 1401280, 1401680, 1401880, 1410420, 1410620, 1410830Medi-Globe Corp.20030—
+2K213578Balloon Dilatation CatheterHangzhou AGS MedTech Co., Ltd.20220—
+2K112994Cre Ditatation BallonBoston Scientific Corporation2012156
+3K253987BARE Wireguided Balloon Dilation Catheter (1235)GIE Medical20260—
+3K241888Single-use Balloon Dilatation CatheterLeo Medical Co., Ltd.20240—
+3K232245VedDilator ^TM (3-Stage Balloon Dilation Catheter)Jiangsu Vedkang Medical Science and Technology Co., Ltd.20240—
+3K222663MultiStage Balloon Dilatation CatheterDongguan TT Medical, Inc.20230—
+3K180086Gyrus ACMI – EZDilate 3-Stage Balloon Dilatation CatheterGyrus Acmi, Inc.2018013
+3K172520CRE RX Biliary Balloon Dilatation CatheterBoston Scientific Corporation20171—
+3K151925Elation Wireguided Balloon Dilation CatheterMerit Medical Systems, Inc.20150—
+3K151671Disposable Multistage Dilation Balloon CatheterMicro-Tech (Nanjing) Co., Ltd.20154—
+3K150142Single Use Balloon Dilator V (with Knife)Olympus Medical Systems Corp.20151—
+3K143609Gyrus ACMI - EZDilate 3-Stage Balloon Dilatation CatheterOlympus Surgical Technologies America20151—
+4K193039Single Use Balloon Dilator V (with knife)Olympus Medical Systems Corp.20190—
+4K162226Reliant Multistage Dilatation Balloon CatheterMicro-Tech (Nanjing) Co., Ltd.20173—
+5K180418Reliant (TM) Multistage Dilatation Balloon CatheterMicro-Tech (Nanjing) Co., Ltd.20182—
+6K253393Single-use Balloon Dilatation Catheter (AG-5251-083018 AG-5251-085518 AG-5251-088018…Hangzhou AGS MedTech Co., Ltd.20260—
+6K253832Dilation Balloon CatheterMirco-Tech (Nanjing) Co., Ltd.20260—