510(k) Report

Devices descending from K151671

4 later devices reach Disposable Multistage Dilation Balloon Catheter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K162226Reliant Multistage Dilatation Balloon CatheterMicro-Tech (Nanjing) Co., Ltd.20173—
+2K180418Reliant (TM) Multistage Dilatation Balloon CatheterMicro-Tech (Nanjing) Co., Ltd.20182—
+3K253393Single-use Balloon Dilatation Catheter (AG-5251-083018 AG-5251-085518 AG-5251-088018…Hangzhou AGS MedTech Co., Ltd.20260—
+3K253832Dilation Balloon CatheterMirco-Tech (Nanjing) Co., Ltd.20260—