510(k) Report

Devices descending from K122917

11 later devices reach Coda Balloon Catheter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K150970Coda LP Balloon CatheterCook Incorporated201510—
+2K151821ER-REBOA CatheterPryor Medical Devices, Inc.20159—
+3K170411ER-REBOA CatheterPrytime Medical Devices, Inc.20178—
+4K210358Neurescue deviceNeurescue Aps20211—
+4K201652COBRA-OS KitFront Line Medical Technologies, Inc.20210—
+4K172790ER-REBOA CatheterPrytime Medical Devices, Inc.20174—
+5K221294preCARDIA Occlusion SystemAbiomed, Inc.20230—
+5K214060LANDMARK REBOA CatheterZien Medical Technologies, Inc.20220—
+5K200459pREBOA-PRO CatheterPrytime Medical Devices, Inc.20201—
+5K193440ER-REBOA PLUS CatheterPrytime Medical Devices, Inc.202001
+6K243795pREBOA-PRO CatheterPrytime Medical Devices, Inc.20250—