510(k) Report

Devices descending from K021721

33 later devices reach Equalizer Balloon Catheter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K140273Equalizer Occlusion Balloon CatheterBoston Scientific Corp201417—
+1K091624Stent Graft Balloon CatheterVia Biomedical, Inc.20093—
+1K081799Gore Tri-Lobe Balloon CatheterW. L. Gore & Associates, Inc.20082—
+1K070126Occlusion Balloon CatheterSentreheart, Inc.20080—
+1K051137Techdevice Occlusion Balloon CatheterTechdevice Corporation200611
+1K033670Gore Tri-Lobe Balloon CatheterW. L. Gore & Associates, Inc.20047—
+2K243184SAT CenterFlow Molding Balloon Catheter (IN20-00313)Strait Access Technologies Holdings20250—
+2K250410GORE® Tri-Lobe Balloon CatheterW. L. Gore & Associates, Inc.20250—
+2K192786Gatekeeper Balloon CatheterArch Catheter, LLC20200—
+2K170411ER-REBOA CatheterPrytime Medical Devices, Inc.20178—
+2K160067RenovoCathRenovorx, Inc.20172—
+2K153530Bridge Occlusion BalloonSpectranetics, Inc.20164Class I
+2K120381Q50 Plus Stent Graft Balloon CatheterQxmedical, LLC20122—
+2K110891The Unballoon Non-Occlusive Catheter; the Unballoon Non-Occlusive Modeling CatheterLeMaitre Vascular, Inc.20113—
+2K094048Percupro Messenger Balloon CatheterCardiosolutions, Inc.20110—
+3K251358Bridge Plus Occlusion Balloon (590-002)Philips Image Guided Therapy Devices20250—
+3K210358Neurescue deviceNeurescue Aps20211—
+3K201652COBRA-OS KitFront Line Medical Technologies, Inc.20210—
+3K203540Bridge Occlusion BalloonSpectranetics, Inc.20200—
+3K191606RenovoCathRenovorx, Inc.20191—
+3K183679Occlusion Balloon CatheterQxmedical, LLC20192—
+3K172567GORE Molding and Occlusion Balloon CatheterW. L. Gore and Associates, Inc.201801
+3K172790ER-REBOA CatheterPrytime Medical Devices, Inc.20174—
+3K133026Unballoon Non-Occlusion Modeling CatheterLeMaitre Vascular, Inc.20130—
+3K123531Unballoon Non-Occlusive Modeling CatheterLeMaitre Vascular, Inc.20121—
+3K121839Unballoon Non-Occlusive Modeling CatheterLeMaitre Vascular, Inc.20122—
+4K221294preCARDIA Occlusion SystemAbiomed, Inc.20230—
+4K214060LANDMARK REBOA CatheterZien Medical Technologies, Inc.20220—
+4K212324RenovoCathRenovorx, Inc.20210—
+4K210602AortaSTAT Occlusion DeviceRenalpro Medical, Inc.20210—
+4K200459pREBOA-PRO CatheterPrytime Medical Devices, Inc.20201—
+4K193440ER-REBOA PLUS CatheterPrytime Medical Devices, Inc.202001
+5K243795pREBOA-PRO CatheterPrytime Medical Devices, Inc.20250—