510(k) Report

Devices descending from K042538

57 later devices reach Sailor Plus Percutaneous Transluminal Angioplasty (Pta) Catheter, Model… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K082646Optimus 0.035 Pta Balloon Dilatation CatheterUsci Ireland20080—
+1K080264Modification to: Fox Plus Pta CatheterAbbott Vascular-Vascular Solutions20081—
+1K062809Admiral Xtreme Pta CatheterInvatec Innovative Technologies200653—
+2K173515Admiral XtremeMedtronic Vascular20180—
+2K103354Ebony Pta .035 Peripheral Dilatation CatheterNatec Medical, Ltd.20112—
+2K100921Admiral Xtreme Pta Balloon Dilatation CatheterInvatec S.P.A.201012—
+2K092361Reef HP 0.035 Otw Pta Balloon Dilatation CatheterInvatec S.P.A.20093—
+2K082579Evercross .035 Otw Pta Dilatation CatheterEv3, Inc.2008351
+2K080925Fox Plus Pta CatheterAbbott Vascular, Inc.20080—
+3K152080Metacross OTW PTA Balloon Dilatation CatheterKANEKA Corporation20151—
+3K150865Metacross RX PTA Balloon Dilitation CatheterKANEKA Corporation20154—
+3K143041Ebony PTA 0.014'' over the wire Catheter and Ebony PTA 0.018 over the wire CatheterNatec Medical, Ltd.20150—
+3K143036Ebony PTA 0.035 Peripheral Dilatation CatheterNatec Medical, Ltd.20150—
+3K123358Pacific PlusMedtronic Vascular20131—
+3K121265Amphirion Plus Pta CatheterMedtronic, Inc.20120—
+3K111899Armada 35/35LL Pta CatheterAbbott Vascular201101
+3K110319Evercross 0.035 Otw Pta Dilatation CatheterEv3, Inc.20115—
+3K103534Gliderxtreme Pta Balloon Catheter (CB) (Over the Wire) 0.014 / 0.018 Guide WireTrireme Medical, Inc.20116—
+3K103464Pacific Xtreme Ptca Balloon Dilatation CatheterMedtronic, Inc.201091
+3K101062Glider Pta Balloon CatheterTrireme Medical, Inc.20108—
+3K093286Powercross .018 Otw Pta Dilation CatheterEv3, Inc.2009142
+4K202800Pacific Plus PTA CatheterMedtronic Vascular,Inc (Formerly D.B.A Ev3 Inc.,Covidien, LLC)20200—
+4K190753EverCrossTM 0.035 OTW PTA Dilatation CatheterMedtronic, Inc. (Formerly D.B.A. Ev3, Inc. Covidien, LLC.)20190—
+4K163479R2P Metacross RXKANEKA Corporation20170—
+4K160004Crosstella OTWKANEKA Corporation20162—
+4K160013Crosperio OTWKANEKA Corporation20160—
+4K152873Crosstella RX Balloon Dilatation CatheterKANEKA Corporation20161—
+4K152887Crosperio RX PTA Balloon Dilatation CatheterKANEKA Corporation20160—
+4K151141Cronus HP - High Pressure Peripheral Balloon CatheterNipro Medical Corporation20161—
+4K142654Fortrex 0.035 OTW PTA Balloon CatheterCovidien, LLC20140—
+4K141118Nanocross Eite 0.014 Over-the-Wire Pta Balloon Dilatation CatheterEv3, Inc.201451
+4K133843Saber Percutaneous Transluminal Angioplasty Dilatation CatheterCordis Corporation201461
+4K130911Rapidcross Pta Rapid Exchange Balloon Dilatation CatheterEv3, Inc.20137—
+4K123544Rapidcross Pta Rapid Exchange, Balloon Dilatation CatheterEv3, Inc.20138—
+4K122070Chocolate Pta Balloon Catheter (Over the Wire) 0.014 Guide Wire, Chocolate Pta Balloon…Trireme Medical, Inc.20122—
+4K121402Chocolate Pta Balloon Catheter (Over the Wire) 0.014 Guide Wire Chocolate Pta Balloon…Trireme Medical, Inc.20123—
+4K120677Chocolate Pta Ballon Catheter (Over the Wire) Guide Wire (0.014)Trireme Medical, Inc.20124—
+4K111738Chocolate Pta Balloon Catheter (Over the Wire) Guide Wire (0.014 and 0.018)Trireme Medical, Inc.20115—
+4K112281Gliderxtreme Pta Ballon Catheter (Over the Wire) 0.018 Guide Wire 6100-Xxxxx, 6100CB-XXXXTrireme Medical, Inc.20114—
+5K240653SmartCardia 7L Platform (MCT)Smartcardia SA20241—
+5K221245PTA Balloon Dilatation CatheterKossel Medtech (Suzhou) Co., Ltd.20220—
+5K201377SABERX RADIANZ Percutaneous Transluminal Angioplasty Dilatation CatheterCordis Corporation20200—
+5K190037Cronus HP PTA Balloon CatheterNipro Medical Corporation20190—
+5K160941Castor, Achilles and Hermes NC PTA Balloon Dilatation CatheterBrosmed Medical Co., Ltd.201601
+5K160256Polux , Minerva and Atropos PTA Balloon Dilatation CatheterBrosmed Medical Co., Ltd.20161—
+5K151153Pirouette 018Arravasc Limited20154—
+5K142459Ebony PTA 0.014 RX Peripheral Dilatation CatheterNatec Medical, Ltd.20151—
+5K132777Nanocross Elite .14 Over-the-Wire Pta, Balloon Dilation CatheterEv3, Inc.20136—
+5K130414Chocolate Pta Balloon Catheter (Over the Wire) 0.014 Guide Wire, Chocolate Pta Balloon…Trireme Medical, Inc.20131—
+6K243349BodyGuardian Remote Monitoring System (BGRMS v3.0)Boston Scientific Cardiac Diagnostic Technologies, Inc.20260—
+6K243704Parafleet SC 014 PTA Balloon Dilatation Catheter; Parafleet SC 018 PTA Balloon…Brosmed Medical Co., Ltd.20250—
+6K213631Chocolate PTA Balloon CatheterMedtronic, Inc.20210—
+6K173621Advocate PTA CatheterMerit Medical Systems, Inc.20171—
+6K162316Pirouette 014Arravasc, Ltd.20162—
+6K161427Pirouette 035Arravasc Limited20162—
+6K152230Ebony PTA .014 RX Pheripheral Dilatation CatheterNatec Medical201501
+7K192907Advocate PTA CatheterMerit Medical Systems, Inc.20190—