510(k) Report

Devices descending from K011889

20 later devices reach Ultra -Thin SDS Balloon Dilatation Catheter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K082339Enabler-P Support CatheterEndocross, Ltd.200814—
+1K021630Boston Scientific Express Biliary LD Premounted Stent SystemBoston Scientific Corp20024—
+2K133110Express LD Biliary Premounted Stent SystemBoston Scientific Corporation20140—
+2K120964Upstream GR CatheterUpstream Peripheral Technologies20120—
+2K092174Enabler-P Catheter System, Model 3000Endocross, Ltd.20099—
+2K083833Enabler-P Catheter, 1000 Part Number:1160Endocross, Ltd.200912—
+2K032360Modification to Boston Scientific Express Biliary LD Premounted Stent System and Express…Boston Scientific Corp20031—
+2K030645Boston Scientific Express Biliary LD Unmounted StentBoston Scientific Corp20032—
+2K024048Modification to Boston Scientific Express Biliary LD Premounted Stent SystemBoston Scientific Scimed, Inc.20033—
+3K151896Houdini CatheterCruzar Medsystems, Inc.20151—
+3K121763Multicross Support CatheterRoxwood Medical, Inc.20128—
+4K213466Houdini Cross Support CatheterCruzar Medsystems, Inc.20220—
+4K152957MultiCross CatheterRoxwood Medical, Inc.20160—
+4K143608NovaCross MicrocatheterNitiloop, Ltd.20152—
+4K140910Centercross CatheterRoxwood Medical, Inc.20143—
+5K172297NovaCross MicrocatheterNitiloop, Ltd.20170—
+5K160389NovaCross MicrocatheterNitiloop, Ltd.20161—
+5K152456CenterCross Ultra CatheterRoxwood Medical, Inc.20162—
+6K160681CenterCross Ultra CatheterRoxwood Medical, Inc.20161—
+7K170403CenterCross Ultra LV CatheterRoxwood Medical, Inc.20170—