510(k) Report

Devices descending from K040498

12 later devices reach Myshell through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K143252Galt Tork, 0.010 to 0.020 inches (yellow), Galt Tork, 0.025 to 0.040 inches (orange)Needle Tech Products, Inc.20150—
+1K080472Sedat Myshell LiteSedat20080—
+1K072552Merit Medical Systems, Inc., Guide Wire Torque DeviceMerit Medical Systems, Inc.20073—
+1K042449Dolphin Inflation DeviceSedat S.A.200554
+2K122152Oxti Inflation DeviceOxti Corporation20120—
+2K112674Navis TorquerNavis Medical,Inc20120—
+2K100425Haskal Torque DeviceElcam Medical Acal20100—
+2K093822Docking Station,Teirstein Edge,Angioassist Combination Device, Angioassist FamilyShepherd Scientific, Inc.20100—
+2K082755Sedat FlamingoSedat200831
+3K152387Fluent Inflation DeviceVascular Solutions, Inc.20151—
+3K123831Ophtacath KitFrance Chirurgae Instrumentation20130—
+4K162272Fluent inflation deviceVascular Solutions, Inc.20160—