510(k) Report

Devices descending from K003159

76 later devices reach Cordis Slalom Pta Balloon Catheter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K013581Cordis Aviator Peripheral Dilatation CatheterCordis, A Johnson & Johnson Co.200165—
+1K012056Cordis Palmaz Genesis Transhepatic Biliary Stent on Slalom .018 Delivery SystemCordis Europa, N.V.20019—
+2K100303Angiosculpt Pta Scoring Balloon Catheter Model 2039-Xxyy, 2076-Xxyy, 2092-Xxyy, 2105-XxyyAngioscore, Inc.201032—
+2K080151Angiosculpt Pta Scoring Balloon Catheter, Models 2076 and 2039Angioscore, Inc.2008365
+2K050629Angiosculpt Scoring Balloon CatheterAngioscore, Inc.200538—
+2K050645Cordis Amiia .014 Pta Balloon CatheterCordis Corp.200525—
+2K040413Cordis Palmaz Blue Transhepatic Biliary Stent on Slalom .018 Delivery SystemCordis Europa, N.V.20042—
+2K012590Cordis Palmaz Genesis Transhepatic Biliary Stent on Opta Pro .035 Delivery SystemCordis Corp.20015—
+3K112182Angiosculpt Pta Scoring Balloon CatheterAngioscore, Inc.201129—
+3K110767Angiosculpt Pta Scoring Balloon CatheterAngioscore, Inc.201130—
+3K101735Angiosculpt Pta Scoring Balloon Catheter Model 2039-Xxyy, 2155-XxyyAngioscore, Inc.201029—
+3K092352Scuba Biliary Stent SystemInvatec S.P.A.20100—
+3K091966Angiosculpt Pta Scoring Balloon Catheter, Models 2076-6040, 2092-6040, 2105-6040Angioscore, Inc.200933—
+3K082059Angiosculpt Pta Scoring Balloon CatheterAngioscore, Inc.200834—
+3K081220Modification to Angiosculpt Pta Scoring Balloon CatheterAngioscore, Inc.200834—
+3K072225Angiosculpt Pta Scoring Balloon CatheterAngioscore, Inc.2007375
+3K071189Cordis Aviator Plus Pta Balloon Dilatation CatheterCordis Europa, N.V.200723—
+3K063563Cordis Amila Percutaneous Transluminal Angioplasty (Pta) Balloon Dilatation CatheterCordis Europa, N.V.200724—
+3K053454RX Herculink Elite Biliary Stent SystemGuidant Corporation20061—
+3K033909Wavemax Balloon-Expandable Transhepatic Biliary Stent SystemAbbott Laboratories20041—
+3K033394Cordis Palmaz Genesis Transhepatic Billary Stent on Opta Pro .035 Delivery SystemCordis Corp.200311
+3K020809Modification to Cordis Palmaz Genesis Transhepatic Biliary StentCordis Corp.20020—
+4K221414ENROUTE Enflate Transcarotid RX Balloon Dilatation CatheterSilk Road Medical, Inc.20220—
+4K150634AngioSculpt PTA Scoring Baloon CathetersSpectranetrics20156—
+4K142983AngioSculpt PTA Scoring Balloon Catheter with HydroCross CoatingAngioscore, Inc.201516—
+4K133998Angiosculpt Pta Scoring Balloon with Hydrocross CaotingAngioscore, Inc.201424—
+4K122685Angiosculpt Pta Scoring Balloon CatheterAngioscore, Inc.201328—
+4K112797Powerflex Pro Percutaneous Transluminal Angioplasty CatheterCordis Corp.201210—
+4K112513Ebony Pta 0.014 Peripheral Dilatation CatheterNatec Medical, Ltd.20113—
+4K072798Viatrac 14 Plus Peripheral Dilation CatheterAbbott Vascular-Vascular Solutions200861
+4K063481Modification to RX Herculink Elite Biliary Stent SystemAbbott Vascular, Inc.20070—
+4K041962Xpand Balloon-Expandable Transhepatic Biliary Stent System, Models 20587, 20588, 20589…Abbott Laboratories20040—
+5K241478Tri-Wedge PTA Scoring Balloon Dilatation CatheterBrosmed Medical Co., Ltd.20240—
+5K232013Aperta NSE PTA Balloon Dilatation Catheter (AW18-05040040/AA18-05040040…Goodman Co., Ltd.20241—
+5K221057Viatrac 14 Plus Peripheral Dilatation CatheterAbbott Vascular20220—
+5K193495XO Score Percutaneous Transluminal Angioplasty Scoring CatheterTransit Scientific20202—
+5K193181Serranator PTA Serration Balloon CatheterCagent Vascular, LLC20201—
+5K163380Serranator Alto PTA Serration Balloon CatheterCagent Vascular, LLC20172—
+5K161384Lithoplasty Peripheral Balloon Dilatation Catheter, Lithoplasty Generator and Connector…Shockwave Medical, Inc.201613—
+5K152230Ebony PTA .014 RX Pheripheral Dilatation CatheterNatec Medical201501
+5K143041Ebony PTA 0.014'' over the wire Catheter and Ebony PTA 0.018 over the wire CatheterNatec Medical, Ltd.20150—
+5K142459Ebony PTA 0.014 RX Peripheral Dilatation CatheterNatec Medical, Ltd.20151—
+5K121442Powerflex Pro Percutaneous Transluminal Angioplasty CatheterCordis Corporation201292
+5K102705Armada 14 Pta CatheterAbbott Vascular, Inc.20104—
+6K260304WAVE PTA Balloon CatheterWAVE Medical AG20260—
+6K252512Armada™ 14 NC PTA CatheterAbbott Medical20260—
+6K243944Aperta NSE PTA Balloon Dilatation CatheterGoodman Co., Ltd.20250—
+6K250225Bolt Intravascular Lithotripsy (IVL) SystemBolt Medical, Inc.20251—
+6K221986XO Score LP Percutaneous Transluminal Angioplasty Scoring Catheter, XO Score LP CatheterTransit Scientific, LLC20221—
+6K213728Serranator PTA Serration Balloon CatheterCagent Vascular, LLC20211—
+6K203437Serranator PTA Serration Balloon CatheterCagent Vascular, LLC20200—
+6K201333SABER .035 PTA Dilatation CatheterCordis Corporation20201—
+6K163306Lithoplasty Peripheral Balloon Dilatation Catheter; Lithoplasty Generator And Connector…Shockwave Medical, Inc.201610—
+6K151317Armada 18 PTA CatheterAbbott Vascular20150—
+6K133843Saber Percutaneous Transluminal Angioplasty Dilatation CatheterCordis Corporation201461
+6K121352Armada 14XXT Pta CatheterAbbott Vascular20120—
+7K260246SEISMIQ™ Intravascular Lithotripsy SystemBolt Medical, Inc.20260—
+7K232258XO Constrain™ Percutaneous Transluminal Angioplasty Constraining CatheterTransit Scientific, LLC20240—
+7K221245PTA Balloon Dilatation CatheterKossel Medtech (Suzhou) Co., Ltd.20220—
+7K220704Serranator PTA Serration Balloon CatheterCagent Vascular, LLC20220—
+7K210626SABER .035 Percutaneous Transluminal Angioplasty (PTA) Dilatation CatheterCordis Corporation20210—
+7K180958Shockwave M5 Peripheral Intravascular Lithotripsy (IVL) Catheter, lntravascular…Shockwave Medical, Inc.20184—
+7K180454Shockwave Medical Intravascular Lithotripsy (IVL) SystemShockwave Medical, Inc.201841
+7K151153Pirouette 018Arravasc Limited20154—
+8K221852Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave L6 Peripheral IVL…Shockwave Medical, Inc.20221—
+8K203365Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave M5+ Peripheral IVL…Shockwave Medical, Inc.20211—
+8K191840Peripheral Intravascular Lithotripsy (IVL) Catheters, IVL Generator and Connector Cable…Shockwave Medical, Inc.20193—
+8K173621Advocate PTA CatheterMerit Medical Systems, Inc.20171—
+8K162316Pirouette 014Arravasc, Ltd.20162—
+8K161427Pirouette 035Arravasc Limited20162—
+9K242213Shockwave Intravascular Lithotripsy (IVL) System with the Javelin Peripheral…Shockwave Medical, Inc.20240—
+9K240954Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave L6 Peripheral IVL…Shockwave Medical, Inc.20240—
+9K240225Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave E8 Peripheral IVL…Shockwave Medical, Inc.20241—
+9K221041Shockwave Medical Peripheral Intravascular Lithotripsy (IVL) SystemShockwave Medical, Inc.20220—
+9K192907Advocate PTA CatheterMerit Medical Systems, Inc.20190—
+10K262201Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave E8 Peripheral IVL…Shockwave Medical, Inc.20260—