510(k) Report

Devices descending from K050502

3 later devices reach Single Use Balloon Dilator Maxpasstm through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K150142Single Use Balloon Dilator V (with Knife)Olympus Medical Systems Corp.20151—
+1K143303Single Use Biliary Balloon DilatorOlympus Medical Systems Corp.20150—
+2K193039Single Use Balloon Dilator V (with knife)Olympus Medical Systems Corp.20190—