510(k) Report

Devices descending from K820865

2 later devices reach Van-Tec Fascial Dilator through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K172527Amplatz Renal Dilator Set, Catheter for Use with Amplatz Renal Dilator Set, Amplatz…Cook Incorporated20171—
+2K213334Monarch Platform, UrologyAuris Health, Inc.202201