510(k) Report

Devices descending from K063118

3 later devices reach Bard Balloon Dilation Kit with Trifunnel Gastrostomy Tube through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K100173Iyunni 3ID Tri-Funnel Feeding Tube KitSainath Intellectual Properties, LLC20100—
+1K092049Iyunni 3ID Tri-Funnel Gastrostomy Tube KitSainath Intellectual Properties, LLC20092—
+2K102572Iyunni 3ID Suprapubic Cystostomy Tube KitSainath Intellectual Properties, LLC20100—