510(k) Report

Devices descending from K002286

62 later devices reach Ldob Occlusion Balloon Catheter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K070770Gore Balloon SheathW. L. Gore & Associates, Inc.20076—
+1K052844Kavs - Catheter, Models 1107100 & 1107060Richter & Rothe AG20060—
+1K050038Reliant Stent Graft Balloon CatheterMedtronic Endovascular Innovations200511—
+1K041151Kerberos Occluding Guide Catheter and AccessoriesKerberos Proximal Solutions, Inc.200425—
+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—
+2K080987Bridgepoint Medical Stingray Device and AccessoriesBridgepoint Medical2009241
+2K083300Gore Flow Reversal SystemW. L. Gore & Associates, Inc.20095—
+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—
+3K143072ENROUTE Transcarotid Neuroprotection SystemSilk Road Medical, Inc.20152—
+3K133026Unballoon Non-Occlusion Modeling CatheterLeMaitre Vascular, Inc.20130—
+3K123531Unballoon Non-Occlusive Modeling CatheterLeMaitre Vascular, Inc.20121—
+3K123156Gore Flow Reversal System Model GFRS073W. L. Gore & Associates, Inc.20120—
+3K121763Multicross Support CatheterRoxwood Medical, Inc.20128—
+3K121839Unballoon Non-Occlusive Modeling CatheterLeMaitre Vascular, Inc.20122—
+3K120381Q50 Plus Stent Graft Balloon CatheterQxmedical, LLC20122—
+3K111963Bridgepoint Medical Mantaray (TM) CatheterBridgepoint Medical20117—
+3K102725Crossboss Catheter Model M-2000, Stingray Orienting Balloon Catheter Model M-1000…Bridge Medical, Inc.2011111
+3K101591Stingray Orienting Balloon CatheterBridgepoint Medical2010141
+3K092177MO.MA Ultra Proximal Cerebral Protection Device, Model MUS0130069X6Invatec S.P.A.200903
+4K210358Neurescue deviceNeurescue Aps20211—
+4K201652COBRA-OS KitFront Line Medical Technologies, Inc.20210—
+4K193322NovaCross CTO MicrocatheterNitiloop, Ltd.20200—
+4K172567GORE Molding and Occlusion Balloon CatheterW. L. Gore and Associates, Inc.201801
+4K172790ER-REBOA CatheterPrytime Medical Devices, Inc.20174—
+4K153485ENROUTE Transcarotid Neuroprotection SystemSilk Road Medical, Inc.20161Class I
+4K152957MultiCross CatheterRoxwood Medical, Inc.20160—
+4K152401Stingray LP CatheterBoston Scientific Corporation20151—
+4K143608NovaCross MicrocatheterNitiloop, Ltd.20152—
+4K140910Centercross CatheterRoxwood Medical, Inc.20143—
+4K134031Threader Monorail Micro-Dilatation Catheter, Threader Over-the-Wire Micro-Dilatation…Boston Scientific Corporation20140—
+4K122795Stingray GuidewiresBridgepoint Medical201201
+4K120533Bigboss Catheters Mantatay Catheter Mantaray GuidewiresBridgepoint Medical20125—
+4K120129Mantaray CatheterBridgepoint Medical20126—
+5K221294preCARDIA Occlusion SystemAbiomed, Inc.20230—
+5K231176Stingray LP CatheterBoston Scientific20230—
+5K230402ENROUTE® Transcarotid Neuroprotection SystemSilk Road Medical20230Class I
+5K221163Tunnel Crossing CatheterTractus Vascular, LLC20230—
+5K214060LANDMARK REBOA CatheterZien Medical Technologies, Inc.20220—
+5K200459pREBOA-PRO CatheterPrytime Medical Devices, Inc.20201—
+5K193596Wingman 14, Wingman 14C, Wingman 18, Wingman 35Reflow Medical20201—
+5K193440ER-REBOA PLUS CatheterPrytime Medical Devices, Inc.202001
+5K183357XableCath Crossing CatheterXablecath, Inc.20190—
+5K172297NovaCross MicrocatheterNitiloop, Ltd.20170—
+5K160389NovaCross MicrocatheterNitiloop, Ltd.20161—
+5K152456CenterCross Ultra CatheterRoxwood Medical, Inc.20162—
+5K121745Mantaray GuidewiresBridgepoint Medical20120—
+6K262013Kiba CTO Crossing CatheterReflow Medical, Inc.20260—
+6K243795pREBOA-PRO CatheterPrytime Medical Devices, Inc.20250—
+6K160681CenterCross Ultra CatheterRoxwood Medical, Inc.20161—
+7K170403CenterCross Ultra LV CatheterRoxwood Medical, Inc.20170—