510(k) Report

Devices descending from K003495

28 later devices reach Ancure Lliac Balloon Catheter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K050038Reliant Stent Graft Balloon CatheterMedtronic Endovascular Innovations200511—
+1K033670Gore Tri-Lobe Balloon CatheterW. L. Gore & Associates, Inc.20047—
+1K032869Cook Coda Balloon CatheterCook, Inc.200326—
+2K151821ER-REBOA CatheterPryor Medical Devices, Inc.20159—
+2K150970Coda LP Balloon CatheterCook Incorporated201510—
+2K122917Coda Balloon CatheterCook, Inc.201311—
+2K110891The Unballoon Non-Occlusive Catheter; the Unballoon Non-Occlusive Modeling CatheterLeMaitre Vascular, Inc.20113—
+2K101877Occlusion Balloon Catheter Model ObcCook, Inc.20100—
+2K091624Stent Graft Balloon CatheterVia Biomedical, Inc.20093—
+2K081799Gore Tri-Lobe Balloon CatheterW. L. Gore & Associates, Inc.20082—
+2K070126Occlusion Balloon CatheterSentreheart, Inc.20080—
+3K243184SAT CenterFlow Molding Balloon Catheter (IN20-00313)Strait Access Technologies Holdings20250—
+3K250410GORE® Tri-Lobe Balloon CatheterW. L. Gore & Associates, Inc.20250—
+3K192786Gatekeeper Balloon CatheterArch Catheter, LLC20200—
+3K170411ER-REBOA CatheterPrytime Medical Devices, Inc.20178—
+3K133026Unballoon Non-Occlusion Modeling CatheterLeMaitre Vascular, Inc.20130—
+3K123531Unballoon Non-Occlusive Modeling CatheterLeMaitre Vascular, Inc.20121—
+3K121839Unballoon Non-Occlusive Modeling CatheterLeMaitre Vascular, Inc.20122—
+3K120381Q50 Plus Stent Graft Balloon CatheterQxmedical, LLC20122—
+4K210358Neurescue deviceNeurescue Aps20211—
+4K201652COBRA-OS KitFront Line Medical Technologies, Inc.20210—
+4K172567GORE Molding and Occlusion Balloon CatheterW. L. Gore and Associates, Inc.201801
+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—