510(k) Report

Devices descending from K093139

9 later devices reach Bantam,48XXXXXX, 50XXXXXX through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K151153Pirouette 018Arravasc Limited20154—
+1K112335Bantam Catheter (280MM Balloon Lengths)ClearStream Technologies, Ltd.20115—
+1K102035Sleek Otw Pta CathetersClearStream Technologies, Ltd.20102—
+2K221832SABER .014 PTA Dilatation Catheter; SABERX .014 PTA Dilatation CatheterCordis US Corp20220—
+2K173621Advocate PTA CatheterMerit Medical Systems, Inc.20171—
+2K162316Pirouette 014Arravasc, Ltd.20162—
+2K161427Pirouette 035Arravasc Limited20162—
+2K130786Sleek Otw Pta CatheterC.R. Bard, Inc.20130—
+3K192907Advocate PTA CatheterMerit Medical Systems, Inc.20190—