510(k) Report

Devices descending from K053118

62 later devices reach Sterling Monorail Pta Balloon Dilatation Catheter, Model H74939031-Xxxxxx through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K162350Coyote Monorail Percutaneous Transluminal Angioplasty Balloon Dilatation Catheter…Boston Scientific Corporation20161—
+1K141150Pta Balloon Dilatation CatheterBoston Scientific Corp20148—
+1K123544Rapidcross Pta Rapid Exchange, Balloon Dilatation CatheterEv3, Inc.20138—
+1K121175Flash Pta Ballon Dilatation Catheter-5MM X 19MM X 135CMOstial Corporation20123—
+1K110604VBB SystemSynthes201111
+1K102482Flash Pta Balloon Dilatation Catheter 5MM X 19MM X 135CM; Flash Pta Balloon Dilatation…Ostial Corporation20115—
+1K093720Sterling SL Monorail Pta Balloon Dilatation Catheters Sterling SL Over-the-Wire Balloon…Boston Scientific Corp200921—
+1K072798Viatrac 14 Plus Peripheral Dilation CatheterAbbott Vascular-Vascular Solutions200861
+1K063563Cordis Amila Percutaneous Transluminal Angioplasty (Pta) Balloon Dilatation CatheterCordis Europa, N.V.200724—
+2K241683Sterling™ MONORAIL™ PTA Balloon Dilatation Catheter (H74939031404020 ); Sterling™…Boston Scientific Corporation20240—
+2K221057Viatrac 14 Plus Peripheral Dilatation CatheterAbbott Vascular20220—
+2K181128Paladin Carotid Post-dilation Balloon System with Integrated Embolic Protection (Paladin…Contego Medical, LLC20181—
+2K173894Jade PTA Balloon Dilatation CatheterOrbusneich Medical Trading, Inc.20183—
+2K142459Ebony PTA 0.014 RX Peripheral Dilatation CatheterNatec Medical, Ltd.20151—
+2K133861Flash Ostial System Otw-7.0MMX17MMX135CM, Flash Ostial System Otw-7.0MMX17MMX80CMOstial Corporation20141—
+2K130911Rapidcross Pta Rapid Exchange Balloon Dilatation CatheterEv3, Inc.20137—
+2K130146Synthes Synflate Vertevral Balloon SystemSynthes (Usa), LLC20130—
+2K122379Flash Pta Balloon Dilatation Catheter - 4MM X 14MM X 135CM, Flash Pta Balloon Dilatation…Ostial Corporation201221
+2K120805Proteus Pta Balloon Catheter with Embolic Capture FeatureAngioslide, Ltd.20123—
+2K120738Flash Pta Balloon Dilatation Catheter-4.0X14MMX135CMOstial Corporation20124—
+2K111295.014 Monorail and Otw Pta Balloon Dilatation CathetersBoston Scientific Corporation201193
+2K102705Armada 14 Pta CatheterAbbott Vascular, Inc.20104—
+2K071189Cordis Aviator Plus Pta Balloon Dilatation CatheterCordis Europa, N.V.200723—
+3K260304WAVE PTA Balloon CatheterWAVE Medical AG20260—
+3K252512Armada™ 14 NC PTA CatheterAbbott Medical20260—
+3K221414ENROUTE Enflate Transcarotid RX Balloon Dilatation CatheterSilk Road Medical, Inc.20220—
+3K221339Paladin Carotid Post-Dilation Balloon System with Integrated Embolic ProtectionContego Medical, Inc.20220—
+3K202231JADEOrbusNeich Medical (Shenzhen) Co., Ltd.20201—
+3K201794JadeOrbusNeich Medical (Shenzhen) Co., Ltd.20201—
+3K152230Ebony PTA .014 RX Pheripheral Dilatation CatheterNatec Medical201501
+3K150452ComboCath OTW PTA Dilatation CatheterSumma Therapeutics, LLC20151—
+3K151317Armada 18 PTA CatheterAbbott Vascular20150—
+3K150946FLASH Ostial System OTW-6.0mm x 12mm x 80cm, FLASH Ostial System OTW-6.0mm x 12mm x…Ostial Corporation20150—
+3K134031Threader Monorail Micro-Dilatation Catheter, Threader Over-the-Wire Micro-Dilatation…Boston Scientific Corporation20140—
+3K140351Arrow Gpscath Balloon Dilatation CatheterHotspur Technologies,Inc Subsidiary of Teleflex ME20143—
+3K133043Proteus Pta Balloon Catheter with Embolic Capture FeatureAngioslide, Ltd.20132—
+3K132777Nanocross Elite .14 Over-the-Wire Pta, Balloon Dilation CatheterEv3, Inc.20136—
+3K121352Armada 14XXT Pta CatheterAbbott Vascular20120—
+3K112797Powerflex Pro Percutaneous Transluminal Angioplasty CatheterCordis Corp.201210—
+3K112513Ebony Pta 0.014 Peripheral Dilatation CatheterNatec Medical, Ltd.20113—
+4K241025JADE PLUS PTA Balloon Dilatation CatheterOrbusNeich Medical (Shenzhen) Co., Ltd.20240—
+4K230263Finesse™ Injectable PTA Balloon Dilatation CatheterSumma Therapeutics, LLC202301
+4K191275All’InCath 035M PTA Balloon Dilatation CatheterNexstep Medical20200—
+4K172494PROTEUS PTA Balloon Catheter with Embolic Capture FeatureAngioslide, Ltd.20171—
+4K1430930.018 Arrow GPSCath Balloon Dilatation Catheter (150 cm)Hotspur Technologies, Inc.,20150—
+4K143041Ebony PTA 0.014'' over the wire Catheter and Ebony PTA 0.018 over the wire CatheterNatec Medical, Ltd.20150—
+4K142300Arrow GPSCath Balloon Dialation Catheter (150 cm)Hotspur Technologies, Inc.,20141—
+4K141118Nanocross Eite 0.014 Over-the-Wire Pta Balloon Dilatation CatheterEv3, Inc.201451
+4K121442Powerflex Pro Percutaneous Transluminal Angioplasty CatheterCordis Corporation201292
+5K201333SABER .035 PTA Dilatation CatheterCordis Corporation20201—
+5K181529Vanguard IEP Peripheral Balloon Angioplasty System with Integrated Embolic ProtectionContego Medical, LLC20180—
+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—
+5K133843Saber Percutaneous Transluminal Angioplasty Dilatation CatheterCordis Corporation201461
+6K243704Parafleet SC 014 PTA Balloon Dilatation Catheter; Parafleet SC 018 PTA Balloon…Brosmed Medical Co., Ltd.20250—
+6K221245PTA Balloon Dilatation CatheterKossel Medtech (Suzhou) Co., Ltd.20220—
+6K210626SABER .035 Percutaneous Transluminal Angioplasty (PTA) Dilatation CatheterCordis Corporation20210—
+6K151153Pirouette 018Arravasc Limited20154—
+7K173621Advocate PTA CatheterMerit Medical Systems, Inc.20171—
+7K162316Pirouette 014Arravasc, Ltd.20162—
+7K161427Pirouette 035Arravasc Limited20162—
+8K192907Advocate PTA CatheterMerit Medical Systems, Inc.20190—