510(k) Report

Devices descending from K131492

13 later devices reach Modified Flowgate Balloon Guide Catheter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K242392Path BGCCrossroads Neurovascular, Inc.20251—
+1K1537298F FlowGate2 Balloon Guide CatheterConcentric Medical2016102
+2K260938Path BGCCrossroads Neurovascular, Inc.20260—
+2K232437Paragon 8F Balloon Guide CatheterWallaby Medical20230—
+2K221846Artix Ballon Guiding SheathInari Medical20220—
+2K212340EMBOGUARD Balloon Guide CatheterNeuravi Limited20211—
+2K193607BOBBY Balloon Guide CatheterMicroVention, Inc.202011
+2K200910BOSS Balloon Guide CatheterMarblehead Medical20201—
+2K192525087 Balloon Guide Catheter SystemQ'Apel Medical, LLC20190—
+2K190749087 Balloon Guide Catheter SystemQ'Apel20190—
+3K261549BOBBY Balloon Guide CatheterMicroVention, Inc., d/b/a Terumo Neuro20260—
+3K233924EMBOGUARD Balloon Guide CatheterNeuravi Limited20240—
+3K203840BOSS 8F Balloon Guide CatheterMarblehead Medical, LLC20210—