510(k) Report

Devices descending from K052791

30 later devices reach Modification to: Amphirion Deep 0.014 Otw Pta Balloon Catheter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K142954PTA 14 Balloon Dilatation Catheter OTWTexasmedical Technologies, Inc.20150—
+1K123358Pacific PlusMedtronic Vascular20131—
+1K121265Amphirion Plus Pta CatheterMedtronic, Inc.20120—
+1K102645Willow/Elm Pta Balloon Dilatation CatheterCreagh Medical, Ltd.20106—
+1K102705Armada 14 Pta CatheterAbbott Vascular, Inc.20104—
+1K083919Amphirion Deep 0.014 Otw Pta Balloon CatheterInvatec Innovative Technologies, S.R.L.2009261
+1K083139Vipersphere Pta Balloon CatheterCardiovascular Systems, Inc.20080—
+2K260304WAVE PTA Balloon CatheterWAVE Medical AG20260—
+2K252512Armada™ 14 NC PTA CatheterAbbott Medical20260—
+2K230191Arise™ UHP Dilatation CatheterCreagh Medical, Ltd.20230—
+2K202800Pacific Plus PTA CatheterMedtronic Vascular,Inc (Formerly D.B.A Ev3 Inc.,Covidien, LLC)20200—
+2K171251014 Hydrophilic Coated PTA Balloon Dilatation CatheterCreagh Medical20172—
+2K151317Armada 18 PTA CatheterAbbott Vascular20150—
+2K143561ELM PTA Balloon Dilatation CatheterO'Connell Regulatory Consultants, Inc.20150—
+2K121352Armada 14XXT Pta CatheterAbbott Vascular20120—
+2K113468Elm Pta Ballon Dilatation CatheterCreagh Medical, Ltd.20110—
+2K112513Ebony Pta 0.014 Peripheral Dilatation CatheterNatec Medical, Ltd.20113—
+2K103464Pacific Xtreme Ptca Balloon Dilatation CatheterMedtronic, Inc.201091
+3K200700Surmodics Sublime Radial Access 014 RX PTA (Percutaneous Transluminal Angioplasty)…Creagh Medical, Ltd.20201—
+3K152230Ebony PTA .014 RX Pheripheral Dilatation CatheterNatec Medical201501
+3K143041Ebony PTA 0.014'' over the wire Catheter and Ebony PTA 0.018 over the wire CatheterNatec Medical, Ltd.20150—
+3K142459Ebony PTA 0.014 RX Peripheral Dilatation CatheterNatec Medical, Ltd.20151—
+3K133843Saber Percutaneous Transluminal Angioplasty Dilatation CatheterCordis Corporation201461
+4K221245PTA Balloon Dilatation CatheterKossel Medtech (Suzhou) Co., Ltd.20220—
+4K211044Sublime Radial Access 018 RX Dilatation CatheterCreagh Medical Ltd. (A Wholly Owned Subsidiary of Surmodics,20210—
+4K151153Pirouette 018Arravasc Limited20154—
+5K173621Advocate PTA CatheterMerit Medical Systems, Inc.20171—
+5K162316Pirouette 014Arravasc, Ltd.20162—
+5K161427Pirouette 035Arravasc Limited20162—
+6K192907Advocate PTA CatheterMerit Medical Systems, Inc.20190—