510(k) Report

Devices descending from K994155

120 later devices reach Excelsior 1018 Microcatheter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K140296Clearlumen Thrombectomy SystemWalk Vascular, LLC20142—
+6K113757Aspire Max Aspiration CatheterControl Medical Technology, LLC20125—
+6K083335Modified Omniwave Endovascular SystemOmnisonics Medical Technologies20080—
+6K071826The Rinspirator, Models FG09770, FG08776, FG08777, FG08910Fox Hollow Technologies20070—
+7K254046BosCATH Support CatheterSonorous NV, Inc.20260—
+7K241388Rist 079 Radial Access Guide Catheter; Rist 071 Radial Access Guide Catheter; Rist…Micro Therapeutics, Inc. d/b/a ev3 Neurovascular20251—
+7K233350SINC Support CatheterReflow Medical, Inc.20240—
+7K231600SENDERO MicrocatheterOkami Medical, Inc.20232—
+7K220780ROVO Mechanical Thrombectomy Device2mg, Inc.20231—
+7K201811coraForce and coraFlex Support CathetersReflow Medical, Inc.20201—
+7K200629Aspire Mechanical Aspirator GControl Medical Technology20200—
+7K200871Aspire MAX 7 - 11F Mechanical Thrombectomy System and Aspire Mechanical AspiratorControl Medical Technology20201—
+7K161786ClearLumen II Thrombectomy SystemWalk Vascular, LLC20161—
+8K254178SAYA 86 Radial Access Guide CatheterAsahi Intecc Co., Ltd.20260—
+8K253730RoVo Mechanical Thrombectomy SystemVerge Medical, Inc.20260—
+8K251277CoraForce Microcatheter, CoraFlex MicrocatheterReflow Medical, Inc.20250—
+8K250013VentiV 7Fr -12Fr MP Mechanical Thrombectomy System (VS7-MP60S, VS7-MP90S, VS8-MP60S…Control Medical Technology, Inc. / Dba Ventiv Scientific20250—
+8K240384SENDERO MicrocatheterOkami Medical, Inc.20241—
+8K163051ClearLumen II Peripheral Thrombectomy SystemWalk Vascular, LLC20170—
+9K242644SENDERO MAX Delivery CatheterOkami Medical, Inc.20240—