510(k) Report

Devices descending from K030788

5 later devices reach Kamar Annulus Dilator + Sizer; Garrett, Cooley, and Debakey Vessel Dilators through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K163524Vessel DilatorFetzer Medical GmbH & Co. KG20170—
+1K131446Integra Jarit Heparin Cannulas, Injectors, and NeedlesIntegra LifeSciences Corporation20130—
+1K100518Instrumed Vessel Dilators, Model 65-7XX,65-9XXX,66-1XXX,65-7048-65-7054Instrumed International, Inc.20103—
+2K183438Geomed Vascular DilatorsGeomed Medizin-Technik GmbH & Co.20191—
+3K220981SUPERPLAST Double-Occluder, SUPERPLAST Vascular ProbeFehling Surgical Instruments, Inc.20230—