510(k) Report

Devices descending from K002254

14 later devices reach Cook Pressure Monitoring Catheter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K180846Arterial Pressure Monitoring Set/TrayCook Incorporated201821
+1K180792Arterial Pressure Monitoring Set/TrayCook Incorporated20182—
+1K151821ER-REBOA CatheterPryor Medical Devices, Inc.20159—
+2K254278Arterial Pressure Monitoring Set/TraySpectrum Vascular20261—
+2K170411ER-REBOA CatheterPrytime Medical Devices, Inc.20178—
+3K261455Arterial Pressure Monitoring Set/TraySpectrum Vascular20260—
+3K210358Neurescue deviceNeurescue Aps20211—
+3K201652COBRA-OS KitFront Line Medical Technologies, Inc.20210—
+3K172790ER-REBOA CatheterPrytime Medical Devices, Inc.20174—
+4K221294preCARDIA Occlusion SystemAbiomed, Inc.20230—
+4K214060LANDMARK REBOA CatheterZien Medical Technologies, Inc.20220—
+4K200459pREBOA-PRO CatheterPrytime Medical Devices, Inc.20201—
+4K193440ER-REBOA PLUS CatheterPrytime Medical Devices, Inc.202001
+5K243795pREBOA-PRO CatheterPrytime Medical Devices, Inc.20250—