510(k) Report

Devices descending from K981359

14 later devices reach GT Leggiero through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K033583ProgreatTerumo Medical Corp.200313—
+2K232536Soldier MicrocatheterEmbolx, Inc.20240—
+2K211078Progreat LambdaTerumo Clinical Supply Co., Ltd.20210—
+2K173430SeQure® NF and SeQure® MicrocathetersAccurate Medical Therapeutics, Ltd.20183—
+2K170223ProgreatAshitaka Factory of Terumo Corporation20171—
+2K142817IntraNovo 25 MicrocatheterTexasmedical Technologies, Inc.20151—
+2K033913ProgreatTerumo Medical Corp.20043—
+3K231293Drakon™ and Sequre® MicrocathetersAccurate Medical Therapeutics20230—
+3K203487Drakon and Sequre MicrocathetersAccurate Medical Therapeutics, Ltd.20201—
+3K202797Drakon and Sequre MicrocathetersAccurate Medical Therapeutics, Ltd.20202—
+3K171665Microcatheter and guide-wire systemSuzhou Hengrui Disheng Medical Co., Ltd.20181—
+3K161967FluidiTube 2.7F Infusion Micro Catheter, 110 cm and 130 cmCallisyn Biomedical, Inc.20170—
+3K153125IntraNovo MicrocatheterTexasmedical Technologies, Inc.20160—
+4K212719Micro Catheter and Guidewire SystemSuzhou Hengrui Hongyuan Medical Co., Ltd.20220—