510(k) Report

Devices descending from K170411

8 later devices reach ER-REBOA Catheter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K210358Neurescue deviceNeurescue Aps20211—
+1K201652COBRA-OS KitFront Line Medical Technologies, Inc.20210—
+1K172790ER-REBOA CatheterPrytime Medical Devices, Inc.20174—
+2K221294preCARDIA Occlusion SystemAbiomed, Inc.20230—
+2K214060LANDMARK REBOA CatheterZien Medical Technologies, Inc.20220—
+2K200459pREBOA-PRO CatheterPrytime Medical Devices, Inc.20201—
+2K193440ER-REBOA PLUS CatheterPrytime Medical Devices, Inc.202001
+3K243795pREBOA-PRO CatheterPrytime Medical Devices, Inc.20250—