510(k) Report

Devices descending from K140273

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K170411ER-REBOA CatheterPrytime Medical Devices, Inc.20178—
+1K160067RenovoCathRenovorx, Inc.20172—
+1K153530Bridge Occlusion BalloonSpectranetics, Inc.20164Class I
+2K251358Bridge Plus Occlusion Balloon (590-002)Philips Image Guided Therapy Devices20250—
+2K210358Neurescue deviceNeurescue Aps20211—
+2K201652COBRA-OS KitFront Line Medical Technologies, Inc.20210—
+2K203540Bridge Occlusion BalloonSpectranetics, Inc.20200—
+2K191606RenovoCathRenovorx, Inc.20191—
+2K183679Occlusion Balloon CatheterQxmedical, LLC20192—
+2K172790ER-REBOA CatheterPrytime Medical Devices, Inc.20174—
+3K221294preCARDIA Occlusion SystemAbiomed, Inc.20230—
+3K214060LANDMARK REBOA CatheterZien Medical Technologies, Inc.20220—
+3K212324RenovoCathRenovorx, Inc.20210—
+3K210602AortaSTAT Occlusion DeviceRenalpro Medical, Inc.20210—
+3K200459pREBOA-PRO CatheterPrytime Medical Devices, Inc.20201—
+3K193440ER-REBOA PLUS CatheterPrytime Medical Devices, Inc.202001
+4K243795pREBOA-PRO CatheterPrytime Medical Devices, Inc.20250—