510(k) Report

Devices descending from K113681

2 later devices reach Gladiator Pta Balloon Dilation Catheter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K132810Gladiator Elite Pta Balloon Dilatation CatheterBoston Scientific Corp20141—
+2K141597Mustang Balloon Dialation CatheterBoston Scientific Corporation20140—