510(k) Report

Devices descending from K920361

4 later devices reach Bard Biliary Balloon Dilators through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K050502Single Use Balloon Dilator MaxpasstmOlympus Winter & Ibe GmbH20053—
+2K150142Single Use Balloon Dilator V (with Knife)Olympus Medical Systems Corp.20151—
+2K143303Single Use Biliary Balloon DilatorOlympus Medical Systems Corp.20150—
+3K193039Single Use Balloon Dilator V (with knife)Olympus Medical Systems Corp.20190—