510(k) Report

Devices descending from K082579

35 later devices reach Evercross .035 Otw Pta Dilatation Catheter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K152080Metacross OTW PTA Balloon Dilatation CatheterKANEKA Corporation20151—
+1K150865Metacross RX PTA Balloon Dilitation CatheterKANEKA Corporation20154—
+1K110319Evercross 0.035 Otw Pta Dilatation CatheterEv3, Inc.20115—
+1K103534Gliderxtreme Pta Balloon Catheter (CB) (Over the Wire) 0.014 / 0.018 Guide WireTrireme Medical, Inc.20116—
+1K101062Glider Pta Balloon CatheterTrireme Medical, Inc.20108—
+1K093286Powercross .018 Otw Pta Dilation CatheterEv3, Inc.2009142
+2K190753EverCrossTM 0.035 OTW PTA Dilatation CatheterMedtronic, Inc. (Formerly D.B.A. Ev3, Inc. Covidien, LLC.)20190—
+2K163479R2P Metacross RXKANEKA Corporation20170—
+2K160004Crosstella OTWKANEKA Corporation20162—
+2K160013Crosperio OTWKANEKA Corporation20160—
+2K152873Crosstella RX Balloon Dilatation CatheterKANEKA Corporation20161—
+2K152887Crosperio RX PTA Balloon Dilatation CatheterKANEKA Corporation20160—
+2K151141Cronus HP - High Pressure Peripheral Balloon CatheterNipro Medical Corporation20161—
+2K142654Fortrex 0.035 OTW PTA Balloon CatheterCovidien, LLC20140—
+2K141118Nanocross Eite 0.014 Over-the-Wire Pta Balloon Dilatation CatheterEv3, Inc.201451
+2K130911Rapidcross Pta Rapid Exchange Balloon Dilatation CatheterEv3, Inc.20137—
+2K123544Rapidcross Pta Rapid Exchange, Balloon Dilatation CatheterEv3, Inc.20138—
+2K122070Chocolate Pta Balloon Catheter (Over the Wire) 0.014 Guide Wire, Chocolate Pta Balloon…Trireme Medical, Inc.20122—
+2K121402Chocolate Pta Balloon Catheter (Over the Wire) 0.014 Guide Wire Chocolate Pta Balloon…Trireme Medical, Inc.20123—
+2K120677Chocolate Pta Ballon Catheter (Over the Wire) Guide Wire (0.014)Trireme Medical, Inc.20124—
+2K111738Chocolate Pta Balloon Catheter (Over the Wire) Guide Wire (0.014 and 0.018)Trireme Medical, Inc.20115—
+2K111899Armada 35/35LL Pta CatheterAbbott Vascular201101
+2K112281Gliderxtreme Pta Ballon Catheter (Over the Wire) 0.018 Guide Wire 6100-Xxxxx, 6100CB-XXXXTrireme Medical, Inc.20114—
+3K240653SmartCardia 7L Platform (MCT)Smartcardia SA20241—
+3K201377SABERX RADIANZ Percutaneous Transluminal Angioplasty Dilatation CatheterCordis Corporation20200—
+3K190037Cronus HP PTA Balloon CatheterNipro Medical Corporation20190—
+3K160941Castor, Achilles and Hermes NC PTA Balloon Dilatation CatheterBrosmed Medical Co., Ltd.201601
+3K160256Polux , Minerva and Atropos PTA Balloon Dilatation CatheterBrosmed Medical Co., Ltd.20161—
+3K142459Ebony PTA 0.014 RX Peripheral Dilatation CatheterNatec Medical, Ltd.20151—
+3K132777Nanocross Elite .14 Over-the-Wire Pta, Balloon Dilation CatheterEv3, Inc.20136—
+3K130414Chocolate Pta Balloon Catheter (Over the Wire) 0.014 Guide Wire, Chocolate Pta Balloon…Trireme Medical, Inc.20131—
+4K243349BodyGuardian Remote Monitoring System (BGRMS v3.0)Boston Scientific Cardiac Diagnostic Technologies, Inc.20260—
+4K243704Parafleet SC 014 PTA Balloon Dilatation Catheter; Parafleet SC 018 PTA Balloon…Brosmed Medical Co., Ltd.20250—
+4K213631Chocolate PTA Balloon CatheterMedtronic, Inc.20210—
+4K152230Ebony PTA .014 RX Pheripheral Dilatation CatheterNatec Medical201501