510(k) Report

Devices descending from K102657

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K112404Concentric Balloon Guide CatheterConcentric Medical, Inc.2012471
+2K220331091 Balloon Guide CatheterInneuroco, Inc.20221—
+2K133177Modified HD Guide CatheterConcentric Medical, Inc.2014283
+2K131492Modified Flowgate Balloon Guide CatheterConcentric Medical, Inc.201313—
+2K122581Modified Balloon Guide Catheter Model 90253, 90254Concentric Medical, Inc.2012151
+3K242392Path BGCCrossroads Neurovascular, Inc.20251—
+3K242301Socrates 38 CatheterScientia Vascular, Inc.20240—
+3K231629091 Balloon Guide CatheterEosolutions, Corp.20230—
+3K202916Balloon Guiding CatheterShanghai Heartcare Medical Technology Co., Ltd.20210—
+3K1537298F FlowGate2 Balloon Guide CatheterConcentric Medical2016102
+3K151667AXS Catalyst Distal Access Catheter 058x115cm, AXS Catalyst Distal Access Catheter…Stryker2015263
+4K260938Path BGCCrossroads Neurovascular, Inc.20260—
+4K234115APRO 55 CatheterAlembic, LLC20244—
+4K233205Distal Access CatheterShanghai Heartcare Medical Technology Co., Ltd.20230—
+4K232437Paragon 8F Balloon Guide CatheterWallaby Medical20230—
+4K221846Artix Ballon Guiding SheathInari Medical20220—
+4K212340EMBOGUARD Balloon Guide CatheterNeuravi Limited20211—
+4K193607BOBBY Balloon Guide CatheterMicroVention, Inc.202011
+4K200910BOSS Balloon Guide CatheterMarblehead Medical20201—
+4K192525087 Balloon Guide Catheter SystemQ'Apel Medical, LLC20190—
+4K190749087 Balloon Guide Catheter SystemQ'Apel20190—
+4K183463AXS Catalyst Distal Access Catheter 068 x 115cm, AXS Catalyst Distal Access Catheter 068…Stryker201914—
+4K182097React 71 CatheterMicro Therapeutics, Inc. d/b/a ev3 Neurovascular20182—
+4K180715React 68 CatheterMicro Therapeutics, Inc. d/b/a ev3 Neurovascular201819—
+5K261549BOBBY Balloon Guide CatheterMicroVention, Inc., d/b/a Terumo Neuro20260—
+5K251097V-DAC CatheterVesalio, Inc.20260—
+5K251014APRO 45 CatheterAlembic, LLC20251—
+5K250962APRO 55 Intermediate CatheterAlembic, LLC20250—
+5K243297APRO 70 Swift CatheterAlembic, LLC20250—
+5K241177React 71 CatheterMicro Therapeutics Lnc. D/B/A Ev3 Neurovascular20240—
+5K233924EMBOGUARD Balloon Guide CatheterNeuravi Limited20240—
+5K231056Esperance Distal Access CatheterWallaby Medical20240—
+5K220716Spartan SC 069Spartan Micro, Inc.20220—
+5K203840BOSS 8F Balloon Guide CatheterMarblehead Medical, LLC20210—
+5K190833AXS Vecta Aspiration CatheterStryker Neurovascular20196—
+5K191237CERENOVUS Large Bore CatheterCodman & Shurtleff, Inc.20195—
+6K262392APRO 35 Swift CatheterAlembic, LLC20260—
+6K221930CEREGLIDE 71 Intermediate CatheterCerenovus, Inc.20231—
+6K202752AXS Vecta 46 Intermediate CatheterStryker Neurovascular20213—
+6K193380CERENOVUS Large Bore Catheter; CERENOVUS Aspiration Tubing SetCodman & Shurtleff, Inc.20203—
+6K200206AXS Vecta 71 Intermediate Catheter, AXS Vecta 74 Intermediate CatheterStryker Neurovascular20201—
+7K261176Zoom 4S CatheterImperative Care, Inc.20260—
+7K251828CEREGLIDE 71 Catheter System; Cerenovus Aspiration Tubing SetCerenovus, Inc.20250—
+7K241768Broadway 8 CatheterStryker Neurovascular20240—
+7K241244CEREGLIDE 42 Intermediate Catheter; CEREGLIDE 57 Intermediate CatheterCerenovus, Inc.20241—
+7K233988Cerenovus Large Bore Catheter; Cerenovus Aspiration Tubing SetCerenovus, Inc.20240—
+7K221934CEREGLIDE 71 Intermediate Catheter; Cerenovus Aspiration Tubing SetCerenovus, Inc.20231—
+8K262398CEREGLIDE 57 Intermediate Catheter; Cerenovus Aspiration Tubing setCERENOVUS, Inc.20260—