510(k) Report

Devices descending from K033535

31 later devices reach Lumend Frontrunner Cto Catheter and Accessories through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K252315Santreva™-ATK Endovascular Revasculariztion CatheterAngioSafe, Inc.20250—
+1K111338Wildcat CatheterAvinger, Inc.201117—
+1K102725Crossboss Catheter Model M-2000, Stingray Orienting Balloon Catheter Model M-1000…Bridge Medical, Inc.2011111
+2K193322NovaCross CTO MicrocatheterNitiloop, Ltd.20200—
+2K152401Stingray LP CatheterBoston Scientific Corporation20151—
+2K134031Threader Monorail Micro-Dilatation Catheter, Threader Over-the-Wire Micro-Dilatation…Boston Scientific Corporation20140—
+2K122795Stingray GuidewiresBridgepoint Medical201201
+2K122380Ocelot SystemAvinger, Inc.201214—
+2K120533Bigboss Catheters Mantatay Catheter Mantaray GuidewiresBridgepoint Medical20125—
+2K120273Kittycat Catheter, Kittycat 2 CatheterAvinger, Inc.20120—
+2K113838Wildcat CatheterAvinger, Inc.20120—
+3K231176Stingray LP CatheterBoston Scientific20230—
+3K221163Tunnel Crossing CatheterTractus Vascular, LLC20230—
+3K193596Wingman 14, Wingman 14C, Wingman 18, Wingman 35Reflow Medical20201—
+3K183357XableCath Crossing CatheterXablecath, Inc.20190—
+3K140185Ocelot Catheter, Ocelot Pixl Catheter, Lightbox ConsoleAvinger, Inc.20147—
+3K123532Ocelot Pixl CatheterAvinger, Inc.201212—
+3K123462Ocelot CatheterAvinger, Inc.20120—
+3K121745Mantaray GuidewiresBridgepoint Medical20120—
+4K262013Kiba CTO Crossing CatheterReflow Medical, Inc.20260—
+4K201330Tigereye CTO-Crossing CatheterAvinger, Inc.20203—
+4K162326Pantheris Catheter, Lightbix HS Imaging Console, Lightbox SledAvinger, Inc.20163—
+4K152275Pantheris SystemAvinger, Inc.20156—
+5K230005Pantheris LV Atherectomy CatheterAvinger, Inc.20230—
+5K230594Tigereye ST CTO-Crossing CatheterAvinger, Inc.20230—
+5K212468Tigereye CTO-Crossing CatheterAvinger, Inc.20220—
+5K172236Pantheris Catheter (8F), Pantheris Catheter (7F), Lightbox HS Imaging Console, Lightbox…Avinger, Inc.20172—
+5K153460Pantheris Catheter (8Fr), Pantheris Catheter (7Fr)Avinger, Inc.20165—
+6K173862Pantheris SystemAvinger, Inc.20181—
+6K160827Pantheris CatheterAvinger, Inc.20164—
+7K212047Pantheris SystemAvinger, Inc.20210—