510(k) Report

Devices descending from K032869

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K151821ER-REBOA CatheterPryor Medical Devices, Inc.20159—
+1K150970Coda LP Balloon CatheterCook Incorporated201510—
+1K122917Coda Balloon CatheterCook, Inc.201311—
+1K110891The Unballoon Non-Occlusive Catheter; the Unballoon Non-Occlusive Modeling CatheterLeMaitre Vascular, Inc.20113—
+1K101877Occlusion Balloon Catheter Model ObcCook, Inc.20100—
+1K091624Stent Graft Balloon CatheterVia Biomedical, Inc.20093—
+1K081799Gore Tri-Lobe Balloon CatheterW. L. Gore & Associates, Inc.20082—
+1K070126Occlusion Balloon CatheterSentreheart, Inc.20080—
+1K050038Reliant Stent Graft Balloon CatheterMedtronic Endovascular Innovations200511—
+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—
+2K133026Unballoon Non-Occlusion Modeling CatheterLeMaitre Vascular, Inc.20130—
+2K123531Unballoon Non-Occlusive Modeling CatheterLeMaitre Vascular, Inc.20121—
+2K121839Unballoon Non-Occlusive Modeling CatheterLeMaitre Vascular, Inc.20122—
+2K120381Q50 Plus Stent Graft Balloon CatheterQxmedical, LLC20122—
+3K210358Neurescue deviceNeurescue Aps20211—
+3K201652COBRA-OS KitFront Line Medical Technologies, Inc.20210—
+3K172567GORE Molding and Occlusion Balloon CatheterW. L. Gore and Associates, Inc.201801
+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—