510(k) Report

Devices descending from K082561

18 later devices reach Spectranetics Quick-Cross Extreme Support Catheters through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K211240ViperCross Support CathetersCardiovascular Systems, Inc.20211—
+1K193420XO Cross Support CatheterTransit Scientific20201—
+1K183305Crossing Support CatheterTractus Vascular, LLC20190—
+1K133539Total AcrossMedtronic Vascular20142—
+1K112886Upstream Support CatheterUpstream Peripheral Technologies20120—
+1K092396Spectranetics Quick Cross Extreme Support CathetersSpectranetics Corp.200913—
+2K233948Provisio™ SLT IVUS™ SystemProvisio Medical, Inc.20240—
+2K214107XO CROSS CORONARY Support CatheterTransit Scientific, LLC20220—
+2K210322XO Cross Support CatheterTransit Scientific, LLC20210—
+2K212725ViperCross Support CathetersCardiovascular Systems, Inc.20210—
+2K180889Tractus Crossing Support CatheterTractus Vascular, LLC20180—
+2K110540Terumo Support CatheterTerumo Medical Corp.20116—
+3K253361Teleport Glide MicrocatheterOrbusNeich Medical (Shenzhen) Co., Ltd.20260—
+3K231044R2P NavicrossTerumo Medical Corporation20231—
+3K220632Boss Crossing Support CatheterMarvao Medical Devices, Ltd.20220—
+3K183000ViperCath XC Peripheral Exchange CatheterCardiovascular Systems, Inc.20181—
+3K173799NaviCross 0.018Terumo Corporation20182—
+4K211251ViperCath XC Peripheral Exchange CatheterCardiovascular Systems, Inc.20210—