510(k) Report

Devices descending from K060224

18 later devices reach Modification to Mira-Flex 18 Microcatheter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K101450Cantata MicrocatheterCook, Inc.20102—
+1K080737Miraflex High Flow MicrocatheterCook, Inc.20083—
+1K072724Cxi Support CatheterCook, Inc.2007131
+2K160884CXI Support CatheterCook Incorporated20162—
+2K131772Cantata (R) 2.9 MicrocatheterCook, Inc.20141—
+2K122796Cxi Support CatheterCook, Inc.20121—
+2K111263Cxi TriforceCook Incorporated20111—
+2K093052Crosscath Support CathterCook, Inc.20097—
+3K222679Vericor Support CatheterVascupatent Medical (Shenzhen) Co., Ltd.20220—
+3K221886Sublime MicrocatheterSurmodics,Inc.20220—
+3K191305Hereaeus Poseidon MicrocatheterHeraeus Medical Components, LLC20190—
+3K191731Instylla MicrocatheterInstylla, Inc.20193—
+3K170931CXI TriForce Peripheral Crossing SetCook Incorporated20170—
+3K162384TrailBlazer Angled Support CatheterMedtronic Vascular, Inc.(Formerly Ev3 Inc.)20160—
+3K161801CrossCath Support CatheterCook Incorporated20160Class I
+4K200744Instylla MicrocatheterInstylla, Inc.20202—
+5K261610Verge™ MicrocatheterInstylla, Inc.20260—
+5K210808Instylla Microcatheter 1.2Instylla, Inc.20211—