510(k) Report

Devices descending from K122581

15 later devices reach Modified Balloon Guide Catheter Model 90253, 90254 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K202916Balloon Guiding CatheterShanghai Heartcare Medical Technology Co., Ltd.20210—
+1K131492Modified Flowgate Balloon Guide CatheterConcentric Medical, Inc.201313—
+2K242392Path BGCCrossroads Neurovascular, Inc.20251—
+2K1537298F FlowGate2 Balloon Guide CatheterConcentric Medical2016102
+3K260938Path BGCCrossroads Neurovascular, Inc.20260—
+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—
+4K261549BOBBY Balloon Guide CatheterMicroVention, Inc., d/b/a Terumo Neuro20260—
+4K233924EMBOGUARD Balloon Guide CatheterNeuravi Limited20240—
+4K203840BOSS 8F Balloon Guide CatheterMarblehead Medical, LLC20210—