510(k) Report

Devices descending from K153729

10 later devices reach 8F FlowGate2 Balloon Guide Catheter through their predicates, nearest generation first.

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