510(k) Report

Devices descending from K112404

47 later devices reach Concentric Balloon Guide Catheter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K220331091 Balloon Guide CatheterInneuroco, Inc.20221—
+1K133177Modified HD Guide CatheterConcentric Medical, Inc.2014283
+1K131492Modified Flowgate Balloon Guide CatheterConcentric Medical, Inc.201313—
+1K122581Modified Balloon Guide Catheter Model 90253, 90254Concentric Medical, Inc.2012151
+2K242392Path BGCCrossroads Neurovascular, Inc.20251—
+2K242301Socrates 38 CatheterScientia Vascular, Inc.20240—
+2K231629091 Balloon Guide CatheterEosolutions, Corp.20230—
+2K202916Balloon Guiding CatheterShanghai Heartcare Medical Technology Co., Ltd.20210—
+2K1537298F FlowGate2 Balloon Guide CatheterConcentric Medical2016102
+2K151667AXS Catalyst Distal Access Catheter 058x115cm, AXS Catalyst Distal Access Catheter…Stryker2015263
+3K260938Path BGCCrossroads Neurovascular, Inc.20260—
+3K234115APRO 55 CatheterAlembic, LLC20244—
+3K233205Distal Access CatheterShanghai Heartcare Medical Technology Co., Ltd.20230—
+3K232437Paragon 8F Balloon Guide CatheterWallaby Medical20230—
+3K221846Artix Ballon Guiding SheathInari Medical20220—
+3K212340EMBOGUARD Balloon Guide CatheterNeuravi Limited20211—
+3K193607BOBBY Balloon Guide CatheterMicroVention, Inc.202011
+3K200910BOSS Balloon Guide CatheterMarblehead Medical20201—
+3K192525087 Balloon Guide Catheter SystemQ'Apel Medical, LLC20190—
+3K190749087 Balloon Guide Catheter SystemQ'Apel20190—
+3K183463AXS Catalyst Distal Access Catheter 068 x 115cm, AXS Catalyst Distal Access Catheter 068…Stryker201914—
+3K182097React 71 CatheterMicro Therapeutics, Inc. d/b/a ev3 Neurovascular20182—
+3K180715React 68 CatheterMicro Therapeutics, Inc. d/b/a ev3 Neurovascular201819—
+4K261549BOBBY Balloon Guide CatheterMicroVention, Inc., d/b/a Terumo Neuro20260—
+4K251097V-DAC CatheterVesalio, Inc.20260—
+4K251014APRO 45 CatheterAlembic, LLC20251—
+4K250962APRO 55 Intermediate CatheterAlembic, LLC20250—
+4K243297APRO 70 Swift CatheterAlembic, LLC20250—
+4K241177React 71 CatheterMicro Therapeutics Lnc. D/B/A Ev3 Neurovascular20240—
+4K233924EMBOGUARD Balloon Guide CatheterNeuravi Limited20240—
+4K231056Esperance Distal Access CatheterWallaby Medical20240—
+4K220716Spartan SC 069Spartan Micro, Inc.20220—
+4K203840BOSS 8F Balloon Guide CatheterMarblehead Medical, LLC20210—
+4K190833AXS Vecta Aspiration CatheterStryker Neurovascular20196—
+4K191237CERENOVUS Large Bore CatheterCodman & Shurtleff, Inc.20195—
+5K262392APRO 35 Swift CatheterAlembic, LLC20260—
+5K221930CEREGLIDE 71 Intermediate CatheterCerenovus, Inc.20231—
+5K202752AXS Vecta 46 Intermediate CatheterStryker Neurovascular20213—
+5K193380CERENOVUS Large Bore Catheter; CERENOVUS Aspiration Tubing SetCodman & Shurtleff, Inc.20203—
+5K200206AXS Vecta 71 Intermediate Catheter, AXS Vecta 74 Intermediate CatheterStryker Neurovascular20201—
+6K261176Zoom 4S CatheterImperative Care, Inc.20260—
+6K251828CEREGLIDE 71 Catheter System; Cerenovus Aspiration Tubing SetCerenovus, Inc.20250—
+6K241768Broadway 8 CatheterStryker Neurovascular20240—
+6K241244CEREGLIDE 42 Intermediate Catheter; CEREGLIDE 57 Intermediate CatheterCerenovus, Inc.20241—
+6K233988Cerenovus Large Bore Catheter; Cerenovus Aspiration Tubing SetCerenovus, Inc.20240—
+6K221934CEREGLIDE 71 Intermediate Catheter; Cerenovus Aspiration Tubing SetCerenovus, Inc.20231—
+7K262398CEREGLIDE 57 Intermediate Catheter; Cerenovus Aspiration Tubing setCERENOVUS, Inc.20260—