510(k) Report

Devices descending from K042537

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K121265Amphirion Plus Pta CatheterMedtronic, Inc.20120—
+1K103464Pacific Xtreme Ptca Balloon Dilatation CatheterMedtronic, Inc.201091
+1K072947Savvy Long and Sleek Peripheral Transluminal Angioplasty (Pta) CathetersClearStream Technologies, Ltd.200879—
+1K050276Diver C.E. CatheterInvatec Innovative Technologies, S.R.L.2005171
+2K221832SABER .014 PTA Dilatation Catheter; SABERX .014 PTA Dilatation CatheterCordis US Corp20220—
+2K133843Saber Percutaneous Transluminal Angioplasty Dilatation CatheterCordis Corporation201461
+2K123358Pacific PlusMedtronic Vascular20131—
+2K112797Powerflex Pro Percutaneous Transluminal Angioplasty CatheterCordis Corp.201210—
+2K100490Litepac, Model 682ClearStream Technologies, Ltd.201012—
+2K093139Bantam,48XXXXXX, 50XXXXXXClearStream Technologies, Ltd.20099—
+2K083919Amphirion Deep 0.014 Otw Pta Balloon CatheterInvatec Innovative Technologies, S.R.L.2009261
+2K083596Reekross Family or Otw Pta CathetersClearStream Technologies, Ltd.20091—
+2K082579Evercross .035 Otw Pta Dilatation CatheterEv3, Inc.2008351
+2K071727QXT Extraction CatheterVascular Solutions, Inc.200712—
+2K060092Quickcat Extraction CatheterKensey Nash Corp.200621
+2K051917Diver C.E. CatheterInvatec Innovative Technologies, S.R.L.2005131
+3K221245PTA Balloon Dilatation CatheterKossel Medtech (Suzhou) Co., Ltd.20220—
+3K202800Pacific Plus PTA CatheterMedtronic Vascular,Inc (Formerly D.B.A Ev3 Inc.,Covidien, LLC)20200—
+3K152080Metacross OTW PTA Balloon Dilatation CatheterKANEKA Corporation20151—
+3K151153Pirouette 018Arravasc Limited20154—
+3K150865Metacross RX PTA Balloon Dilitation CatheterKANEKA Corporation20154—
+3K131199Ultraverse RX Pta Balloon Dilatation CatheterBard Peripheral Vascular, Inc.201311—
+3K121442Powerflex Pro Percutaneous Transluminal Angioplasty CatheterCordis Corporation201292
+3K112513Ebony Pta 0.014 Peripheral Dilatation CatheterNatec Medical, Ltd.20113—
+3K112335Bantam Catheter (280MM Balloon Lengths)ClearStream Technologies, Ltd.20115—
+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—
+3K102645Willow/Elm Pta Balloon Dilatation CatheterCreagh Medical, Ltd.20106—
+3K102705Armada 14 Pta CatheterAbbott Vascular, Inc.20104—
+3K102035Sleek Otw Pta CathetersClearStream Technologies, Ltd.20102—
+3K101361Reeflex Pta CatheterClearStream Technologies, Ltd.20100—
+3K101062Glider Pta Balloon CatheterTrireme Medical, Inc.20108—
+3K093286Powercross .018 Otw Pta Dilation CatheterEv3, Inc.2009142
+3K073519Quickcat Extraction Catheter, Model 60090-01Kensey Nash Corp.200811
+3K072810Pronto Low Profile (LP) Extraction Catheter, Model 5010Vascular Solutions, Inc.200711—
+4K260304WAVE PTA Balloon CatheterWAVE Medical AG20260—
+4K252512Armada™ 14 NC PTA CatheterAbbott Medical20260—
+4K230191Arise™ UHP Dilatation CatheterCreagh Medical, Ltd.20230—
+4K201333SABER .035 PTA Dilatation CatheterCordis Corporation20201—
+4K190753EverCrossTM 0.035 OTW PTA Dilatation CatheterMedtronic, Inc. (Formerly D.B.A. Ev3, Inc. Covidien, LLC.)20190—
+4K180921Sapphire II PRO Balloon Dilatation CatheterOrbusneich Medical Trading, Inc.20183—
+4K173621Advocate PTA CatheterMerit Medical Systems, Inc.20171—
+4K171251014 Hydrophilic Coated PTA Balloon Dilatation CatheterCreagh Medical20172—
+4K171290Vela RX PTA Balloon Dilatation CatheterCuratia Medical20170—
+4K163479R2P Metacross RXKANEKA Corporation20170—
+4K162316Pirouette 014Arravasc, Ltd.20162—
+4K161427Pirouette 035Arravasc Limited20162—
+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—
+4K152230Ebony PTA .014 RX Pheripheral Dilatation CatheterNatec Medical201501
+4K151317Armada 18 PTA CatheterAbbott Vascular20150—
+4K143041Ebony PTA 0.014'' over the wire Catheter and Ebony PTA 0.018 over the wire CatheterNatec Medical, Ltd.20150—
+4K143561ELM PTA Balloon Dilatation CatheterO'Connell Regulatory Consultants, Inc.20150—
+4K142459Ebony PTA 0.014 RX Peripheral Dilatation CatheterNatec Medical, Ltd.20151—
+4K142654Fortrex 0.035 OTW PTA Balloon CatheterCovidien, LLC20140—
+4K141118Nanocross Eite 0.014 Over-the-Wire Pta Balloon Dilatation CatheterEv3, Inc.201451
+4K130911Rapidcross Pta Rapid Exchange Balloon Dilatation CatheterEv3, Inc.20137—
+4K130786Sleek Otw Pta CatheterC.R. Bard, Inc.20130—
+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—
+4K121352Armada 14XXT Pta CatheterAbbott Vascular20120—
+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—
+4K113468Elm Pta Ballon Dilatation CatheterCreagh Medical, Ltd.20110—
+4K111738Chocolate Pta Balloon Catheter (Over the Wire) Guide Wire (0.014 and 0.018)Trireme Medical, Inc.20115—
+4K111899Armada 35/35LL Pta CatheterAbbott Vascular201101
+4K112281Gliderxtreme Pta Ballon Catheter (Over the Wire) 0.018 Guide Wire 6100-Xxxxx, 6100CB-XXXXTrireme Medical, Inc.20114—
+4K091703HD Guide Catheter, Model 90019, 90022, 90023, 90120, 90121, 90130, 90131Concentric Medical, Inc.20090—
+4K083784Pronto V3 Extraction Center, Model 5003, Pronto LP Extraction Catheter, Model 5010…Vascular Solutions, Inc.200910—
+5K252295RyureiTerumo Corporation20260—
+5K240653SmartCardia 7L Platform (MCT)Smartcardia SA20241—
+5K211349Selebrek PTCA Balloon Dilatation CatheterKossel Medtech (Suzhou) Co., Ltd.20220—
+5K210626SABER .035 Percutaneous Transluminal Angioplasty (PTA) Dilatation CatheterCordis Corporation20210—
+5K201377SABERX RADIANZ Percutaneous Transluminal Angioplasty Dilatation CatheterCordis Corporation20200—
+5K200700Surmodics Sublime Radial Access 014 RX PTA (Percutaneous Transluminal Angioplasty)…Creagh Medical, Ltd.20201—
+5K200269Sapphire II PROOrbusneich Medical Trading, Inc.20200—
+5K192907Advocate PTA CatheterMerit Medical Systems, Inc.20190—
+5K190037Cronus HP PTA Balloon CatheterNipro Medical Corporation20190—
+5K162467Twin-Pass TorqueVascular Solutions, Inc.20172—
+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—
+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—
+5K112382Terumo Aspriation CatheterTerumo Medical Corporation20110—
+5K103405Pronto V4 Extraction Catheter 5.5F; Pronto V4 Extraction Catheter 6F; Pronto V4…Vascular Solutions, Inc.201041
+5K090977Piggyback Wire ConverterVascular Solutions, Inc.20090—
+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—
+6K211044Sublime Radial Access 018 RX Dilatation CatheterCreagh Medical Ltd. (A Wholly Owned Subsidiary of Surmodics,20210—
+6K200324NHancer RxImds Operations B.V.20201—
+6K161506Penumbra Aspiration SystemPenumbra, Inc.20163—
+7K210431ReCrossImds Operations B.V.20210—
+7K163618INDIGO Aspiration SystemPenumbra, Inc.20172—
+8K180412Indigo Aspiration System (CAT RX and Separator 4)- Penumbra Engine Pump and CanisterPenumbra, Inc.20181—
+9K220683INDIGO Aspiration System (CAT RX Aspiration Catheter and Separator 4)Penumbra, Inc.20220—