Anesthesiology
Review Panel
- CardiovascularReview Panel
- MiscellaneousMiscellaneous
- Subpart B—Cardiovascular Diagnostic DevicesCFR Sub-Part
- DQDStethoscope, Electronic2Product Code
- DQECatheter, Oximeter, Fiber-Optic2Product Code
- DQGMicrosphere, Trace3Product Code
- DQKComputer, Diagnostic, Programmable2Product Code
- DQOCatheter, Intravascular, Diagnostic2Product Code
- DQPKit, Balloon Repair, Catheter3Product Code
- DQRCannula, Catheter2Product Code
- DQTOccluder, Catheter Tip2Product Code
- DQXWire, Guide, Catheter2Product Code
- DQYCatheter, Percutaneous2Product Code
- K253409C320LBB Delivery System (C320LBBS45), C320LBB Delivery System (C320LBBS48), C320LBB Delivery System (C320LBBL45), C320LBB Delivery System (C320LBBL48)2Cleared 510(K)
- K252417Amplatzer Piccolo™ Delivery System (9-PDS-04F-045)2Cleared 510(K)
- K252390Telescope Guide Extension Catheter2Cleared 510(K)
- K251277CoraForce Microcatheter, CoraFlex Microcatheter2Cleared 510(K)
- K250147CPS Locator 3D Delivery Catheter2Cleared 510(K)
- K250972Primum Hydrophilic Guiding Catheter2Cleared 510(K)
- K250828CPS Locator 3D Plus Delivery Catheter2Cleared 510(K)
- K243184SAT CenterFlow Molding Balloon Catheter (IN20-00313)2Cleared 510(K)
- K250492FlexiGo 3D Delivery Catheter2Cleared 510(K)
- K250219Dorado™ PTA Balloon Dilatation Catheter2Cleared 510(K)
- K250410GORE® Tri-Lobe Balloon Catheter2Cleared 510(K)
- K243757Shockwave CS Guide Catheter2Cleared 510(K)
- K251014APRO 45 Catheter2Cleared 510(K)
- K250962APRO 55 Intermediate Catheter2Cleared 510(K)
- K250426Amulet™ Steerable Delivery Sheath2Cleared 510(K)
- K242337FlowGuide (FG60F); GuidionShort (GS60F)2Cleared 510(K)
- K243691LiquID .051 LP Guide Catheter Extension2Cleared 510(K)
- K250558SelectSite C304 Deflectable Catheter System (C304); C315 Delivery System (C315)2Cleared 510(K)
- K243436Seclusion Catheter2Cleared 510(K)
- K242873Ventrax™ Delivery System2Cleared 510(K)
- K242588COREPASS Modular Microcatheter (FLEX); COREPASS Modular Microcatheter (CONTROL)2Cleared 510(K)
- K243224MitraClip™ G5 Steerable Guide Catheter (SGC0801); TriClip™ G5 Steerable Guide Catheter (TSGC0801)2Cleared 510(K)
- K242644SENDERO MAX Delivery Catheter2Cleared 510(K)
- K240885Shadow Catheter2Cleared 510(K)
- K243180SSPC NXT Delivery Catheter2Cleared 510(K)
- K242276CrossFAST™ Integrated Microcatheter Guide Extension System (CFM55)2Cleared 510(K)
- K240787Selectra 3D Lead Delivery System (443624-443629, 451789-451791); Selectra Slitter Tool (383119); Selectra Accessory Kit (375518)2Cleared 510(K)
- K241611ShapeIT (SI014135)2Cleared 510(K)
- K241538TriClip Steerable Guide Catheter2Cleared 510(K)
- K233637Cordis BRITECROSS Support Catheter2Cleared 510(K)
- K241158ASAHI Veloute; ASAHI Veloute C3; ASAHI Tellus; ASAHI Tellus C32Cleared 510(K)
- K241177React 71 Catheter2Cleared 510(K)
- K234115APRO 55 Catheter2Cleared 510(K)
- K240384SENDERO Microcatheter2Cleared 510(K)
- K233350SINC Support Catheter2Cleared 510(K)
- K240018WATCHMAN TruSteer Access System (M635TU90050)2Cleared 510(K)
- K231608Teleport XT Microcatheter2Cleared 510(K)
- K233858TriSalus TriGuideTM Guiding Catheter2Cleared 510(K)
- K231600SENDERO Microcatheter2Cleared 510(K)
- K231629091 Balloon Guide Catheter2Cleared 510(K)
- K232437Paragon 8F Balloon Guide Catheter2Cleared 510(K)
- K232690Amulet™ Steerable Delivery Sheath2Cleared 510(K)
- K232647Microcatheter2Cleared 510(K)
- K231246Ventrax™ Delivery System (VTR851)2Cleared 510(K)
- K2321906F Sherpa NX Balanced Guide Catheter, 7F Sherpa NX Balanced Guide Catheter2Cleared 510(K)
- K223633Rubicon™ Control Support Catheter (H749394323506A1)2Cleared 510(K)
- K231044R2P Navicross2Cleared 510(K)
- K223728Micro Rx2Cleared 510(K)
- K2301565F Launcher Guide Catheter, 6F Launcher Guide Catheter, 7F Launcher Guide Catheter, 8F Launcher Guide Catheter2Cleared 510(K)
- K231311CPS Direct™ Universal slittable outer guide catheter (DS2C029)2Cleared 510(K)
- K231176Stingray LP Catheter2Cleared 510(K)
- K222023RayFlow2Cleared 510(K)
- K230363CPS Locator 3D Delivery Catheter2Cleared 510(K)
- K2226036F Wallaby Long Sheath2Cleared 510(K)
- K222115ISAAC Neurovascular Navigation Catheter2Cleared 510(K)
- K223178SelectSite C304 Deflectable Catheter System, C315 Delivery System2Cleared 510(K)
- K222873Attain Command + SureValve Delivery System, Attain Select II + SureValve delivery system2Cleared 510(K)
- K213466Houdini Cross Support Catheter2Cleared 510(K)
- K221886Sublime Microcatheter2Cleared 510(K)
- K214024SOFIA 88 Catheter2Cleared 510(K)
- K220647GuideLiner Coast, 5.5F (5270); GuideLiner Coast, 6F (5271); GuideLiner Coast, 7F (5272); GuideLiner Coast, 8F (5273)2Cleared 510(K)
- K220331091 Balloon Guide Catheter2Cleared 510(K)
- K222037Selectra Lead Implantation System2Cleared 510(K)
- K221846Artix Ballon Guiding Sheath2Cleared 510(K)
- K221750CPS AIM Universal II Slittable Inner Catheter2Cleared 510(K)
- K220632Boss Crossing Support Catheter2Cleared 510(K)
- K220716Spartan SC 0692Cleared 510(K)
- K220691LiquID 061 Guide Catheter Extension, LiquID 071 Guide Catheter Extension2Cleared 510(K)
- K212588Conquest 40 PTA Dilatation Catheter, Atlas Gold PTA Dilatation Catheter, Vida PTV Dilatation Catheter, Vida BAV Balloon Valvuloplasty Catheter2Cleared 510(K)
- K214107XO CROSS CORONARY Support Catheter2Cleared 510(K)
- K220340Amplatzer Steerable Delivery Sheath2Cleared 510(K)
- K212211Turnpike catheter, Turnpike Spiral catheter, Turnpike LP catheter, Turnpike Gold catheter, GuideLiner V3 catheter, TrapLiner catheter2Cleared 510(K)
- K214106QuikPass Catheter2Cleared 510(K)
- K210009Guiding Catheter2Cleared 510(K)
- K210322XO Cross Support Catheter2Cleared 510(K)
- K212738Amplatzer Talisman Delivery Sheath2Cleared 510(K)
- K212026Amplatzer Steerable Delivery Sheath2Cleared 510(K)
- K212725ViperCross Support Catheters2Cleared 510(K)
- K211240ViperCross Support Catheters2Cleared 510(K)
- K212228WATCHMAN FXD Curve Access System2Cleared 510(K)
- K211990Rist 071 Radial Access Guide Catheter2Cleared 510(K)
- K201706KDL Micro catheter2Cleared 510(K)
- K210431ReCross2Cleared 510(K)
- K201726Arterial Catheter2Cleared 510(K)
- K210188coraCross2Cleared 510(K)
- K211251ViperCath XC Peripheral Exchange Catheter2Cleared 510(K)
- K210647SuperCross microcatheter, SuperCross FT microcatheter, SuperCross AT microcatheter2Cleared 510(K)
- K210601Plato 17 Microcatheter2Cleared 510(K)
- K210110Guidion2Cleared 510(K)
- K203521FineCross M32Cleared 510(K)
- K203275Recon Support Catheter2Cleared 510(K)
- K210230Phenom Catheters2Cleared 510(K)
- K202610Ventrax Delivery System2Cleared 510(K)
- K201811coraForce and coraFlex Support Catheters2Cleared 510(K)
- K193474Selectra 3D Outer Guiding Catheters2Cleared 510(K)
- K202252ASAHI Corsair Armet 18 Microcatheter (Model: CSAR060-18N), ASAHI Corsair Armet 18 Microcatheter (Model: CSAR090-18N), ASAHI Corsair Armet 18 Microcatheter (Model: CSAR110-18N), ASAHI Corsair Armet 18 Microcatheter (Model: CSAR135-18N),2Cleared 510(K)
- K200324NHancer Rx2Cleared 510(K)
- K192712Attain Select II + SureValve delivery catheter system, Attain Command + SureValve Left Heart Delivery System, Attain Comman + SureValve Guide Catheters for Left Heart Delivery, C315 Delivery Catheter2Cleared 510(K)
- K193607BOBBY Balloon Guide Catheter2Cleared 510(K)
- K193119Twin-Pass Dual Access Catheter2Cleared 510(K)
- K201271Benchmark BMX96 Access System2Cleared 510(K)
- K200721Agilis HisPro Steerable Catheter With Electrodes2Cleared 510(K)
- K200317Support Catheter2Cleared 510(K)
- K193420XO Cross Support Catheter2Cleared 510(K)
- K192558Q3 Distal Access Catheter, Q4 Distal Access Catheter, Q5 Distal Access Catheter, Q6Distal Access Catheter2Cleared 510(K)
- K193322NovaCross CTO Microcatheter2Cleared 510(K)
- K200094speX LP Support Catheter2Cleared 510(K)
- K193596Wingman 14, Wingman 14C, Wingman 18, Wingman 352Cleared 510(K)
- K193012speX Support Catheter2Cleared 510(K)
- K191229TrapIt2Cleared 510(K)
- K191717Route 92 Medical Sheath System2Cleared 510(K)
- K192774BioCardia 8F Morph DNA Deflectable Guide Catheter2Cleared 510(K)
- K192135VIA Microcatheter (size 17), VIA Microcatheter (size 21), VIA Microcatheter (size 27), VIA Microcatheter (size 33)2Cleared 510(K)
- K191551RIST Cath Radial Access Long Sheath2Cleared 510(K)
- K190833AXS Vecta Aspiration Catheter2Cleared 510(K)
- K191163Lumax Guiding Catheter2Cleared 510(K)
- K193034AXS Infinity LS Plus Long Sheath2Cleared 510(K)
- K192782ASAHI CROSSWALK Peripheral Support Catheter2Cleared 510(K)
- K192996Selectra Catheters, Selectra Accessory Kit, Selectra Slitter Tool2Cleared 510(K)
- K192625PG Pro Microcatheter2Cleared 510(K)
- K191237CERENOVUS Large Bore Catheter2Cleared 510(K)
- K192525087 Balloon Guide Catheter System2Cleared 510(K)
- K192296Medtronic 6F Taiga Guiding Catheter2Cleared 510(K)
- K191664SelectFlex 072 Neurovascular Access System2Cleared 510(K)
- K191560Turnpike Catheter; Turnpike Spiral Catheter; Turnpike Gold Catheter; Turnpike LP Catheter2Cleared 510(K)
- K183305Crossing Support Catheter2Cleared 510(K)
- K182487CerusEndo Microcatheter2Cleared 510(K)
- K190749087 Balloon Guide Catheter System2Cleared 510(K)
- K182829Scepter Mini Occlusion Balloon Catheter2Cleared 510(K)
- K190475Delivery Catheter SSPC1, Delivery Catheter SSPC2, Delivery Catheter SSPC3, Delivery Catheter SSPC42Cleared 510(K)
- K182844ASAHI SASUKE2Cleared 510(K)
- K182937Upstream GoBack Crossing Catheter2Cleared 510(K)
- K182602SOFIA EX Intracranial Support Catheter2Cleared 510(K)
- K190393Wingman 14C Crossing Catheter2Cleared 510(K)
- K190581Amplatzer Trevisio Intravascular Delivery System2Cleared 510(K)
- K183353Telescope Guide Extension Catheter2Cleared 510(K)
- K190431Route 92 Medical Delivery Catheter2Cleared 510(K)
- K182918Ballast 088 Long Sheath2Cleared 510(K)
- K190401MAMBA and MAMBA Flex Microcatheters2Cleared 510(K)
- K183493SelectSite C304-HIS Deflectable Catheter System2Cleared 510(K)
- K183463AXS Catalyst Distal Access Catheter 068 x 115cm, AXS Catalyst Distal Access Catheter 068 x 125cm, AXS Catalyst Distal Access Catheter 068 x 132cm2Cleared 510(K)
- K182570Venture 0.014 Catheter2Cleared 510(K)
- K183000ViperCath XC Peripheral Exchange Catheter2Cleared 510(K)
- K182420ASAHI Corsair Pro XS2Cleared 510(K)
- K180797Xcess Guiding Catheter2Cleared 510(K)
- K183265Selectra Catheters, Selectra Accessory Kit2Cleared 510(K)
- K182512Route 92 Medical Delivery Catheter2Cleared 510(K)
- K180889Tractus Crossing Support Catheter2Cleared 510(K)
- K182097React 71 Catheter2Cleared 510(K)
- K182360Teleport Microcatheter2Cleared 510(K)
- K180919GORE Tri-Lumen Catheter2Cleared 510(K)
- K181563The ARTERIAL WAND Safety Introducer with Arterial Catheter made of ChronoFlex C with BioGUARD Technology2Cleared 510(K)
- K181000SelectFlex 072 Neurovascular Access System2Cleared 510(K)
- K180169EagleRay Long Sheath, 0.088 ID, 80cm, 90cm, 100cm and 110cm Lengths, EagleRay Access Catheter, 0.071 ID, 137cm Length, EagleRay Access Catheter, 0.055 ID, 137cm Length, EagleRay Access Catheter, 0.045 ID, 144cm Length, EagleRay Access Catheter, 0.035 ID, 158cm Length2Cleared 510(K)
- K180864WATCHMAN TruSeal Access System2Cleared 510(K)
- K180715React 68 Catheter2Cleared 510(K)
- K180959Phenom 27 Catheter2Cleared 510(K)
- K180201Route 92 Medical Access System2Cleared 510(K)
- K180986XableCath Support Catheter Product Family2Cleared 510(K)
- K173661Wingman 35 Crossing Catheter2Cleared 510(K)
- K172014Wedge Microcatheter2Cleared 510(K)
- K180088TrapLiner catheter2Cleared 510(K)
- K173548Merit Pursue Microcatheter2Cleared 510(K)
- K173799NaviCross 0.0182Cleared 510(K)
- K173709Zenith Support, 95 cm, Zenith Support, 105 cm, Zenith Support, 115 cm2Cleared 510(K)
- K173560Microcatheter2Cleared 510(K)
- K171819Attain Assist CS Access Catheter2Cleared 510(K)
- K173662speX Support Catheter2Cleared 510(K)
- K172468091 Long Sheath, 70 cm, 091 Long Sheath, 80 cm, 091 Long Sheath, 90 cm2Cleared 510(K)
- K170914TXM Support Catheter2Cleared 510(K)
- K170664Odyssey Micro Catheter2Cleared 510(K)
- K172090GuideLiner V3 Catheter2Cleared 510(K)
- K171672065 Zenith, 074 Zenith2Cleared 510(K)
- K172297NovaCross Microcatheter2Cleared 510(K)
- K171176M-CATH Microcatheter2Cleared 510(K)
- K170041XableCath Support Catheter2Cleared 510(K)
- K171452MAMBA and MAMBA FLEX Microcatheters2Cleared 510(K)
- K163259AXS Offset Delivery Assist Catheter2Cleared 510(K)
- K171913Rubicon 14, 18 and 35 Support Catheters2Cleared 510(K)
- K171653YOGA Microcatheter, 0.032, 150cm, Back Up and Extra Back Up2Cleared 510(K)
- K171612ACUITY Pro Lead Delivery System2Cleared 510(K)
- K171146Arrow Seldinger Arterial Catheterization Device 18 ga., Arrow Seldinger Arterial Catheterization Device 20 ga., Arrow Seldinger Arterial Catheterization Device 22 ga., Arrow Seldinger Arterial Catheterization Device 24 ga.2Cleared 510(K)
- K170996Wingman 14C Crossing Catheter2Cleared 510(K)
- K171335Venture 038 catheter2Cleared 510(K)
- K171268Reverse 021 Micro Catheter, Reverse 027 Micro Catheter2Cleared 510(K)
- K163233MIVI 6F 25cm Mi-EXT Extension Catheter, MIVI 5F 25cm Mi-EXT Extension Catheter, MIVI 4F 30cm Mi-EXT Extension Catheter, MIVI 3F 43cm Mi-EXT Extension Catheter2Cleared 510(K)
- K163314Guidezilla II Guide Extension Catheter; Guidezilla II LONG Guide Extension Catheter2Cleared 510(K)
- K170403CenterCross Ultra LV Catheter2Cleared 510(K)
- K162565VIA 17 Microcatheter2Cleared 510(K)
- K161901TrapLiner catheter2Cleared 510(K)
- K162467Twin-Pass Torque2Cleared 510(K)
- K162253Trapper Exchange Device2Cleared 510(K)
- K162563YOGA Microcatheter2Cleared 510(K)
- K163000AMPLATZER TorqVue 45x45 Delivery Sheath2Cleared 510(K)
- K160561Boosting Catheter2Cleared 510(K)
- K161546R2P SlenGuide2Cleared 510(K)
- K161152Navien Intracranial Support Catheter2Cleared 510(K)
- K162384TrailBlazer Angled Support Catheter2Cleared 510(K)
- K162359Surefire Guiding Catheter2Cleared 510(K)
- K161262Super Distal Access (SDA)2Cleared 510(K)
- K162228TorqVue Low Profile Delivery Catheter2Cleared 510(K)
- K161126ASAHI Corsair Pro2Cleared 510(K)
- K161986SIDEKICK and USHER Support Catheters2Cleared 510(K)
- K160848Wingman 18 Crossing Catheter2Cleared 510(K)
- K160448ARTLINE2Cleared 510(K)
- K160681CenterCross Ultra Catheter2Cleared 510(K)
- K161362ASAHI Corsair Armet2Cleared 510(K)
- K153703Guiding Catheter2Cleared 510(K)
- K160389NovaCross Microcatheter2Cleared 510(K)
- K152957MultiCross Catheter2Cleared 510(K)
- K152249ASAHI Corsair Armet2Cleared 510(K)
- K1537298F FlowGate2 Balloon Guide Catheter2Cleared 510(K)
- K152456CenterCross Ultra Catheter2Cleared 510(K)
- K152447ASAHI Caravel2Cleared 510(K)
- K152876LONG SHEATH OR LS, 70 CM, LONG SHEATH OR LS, 80 CM, LONG SHEATH OR LS, 90 CM2Cleared 510(K)
- K152202Intermediate Catheter, 105 cm, Intermediate Catheter, 115cm, Intermediate Catheter , 125cm2Cleared 510(K)
- K151396MIVI Mi-AXUS Guide Catheter2Cleared 510(K)
- K151896Houdini Catheter2Cleared 510(K)
- K152401Stingray LP Catheter2Cleared 510(K)
- K152840Lantern Delivery Microcatheter2Cleared 510(K)
- K151667AXS Catalyst Distal Access Catheter 058x115cm, AXS Catalyst Distal Access Catheter 058x132cm, AXS Catalyst Distal Access Catheter 060x132cm2Cleared 510(K)
- K151638Phenom 17 Catheter, Phenom 21 Catheter, Phenom 27 Catheter, Phenom Plus Catheter2Cleared 510(K)
- K151821ER-REBOA Catheter2Cleared 510(K)
- K150894VIA 21 Microcatheter2Cleared 510(K)
- K151981Turnpike catheter2Cleared 510(K)
- K151880Wingman Crossing Catheter2Cleared 510(K)
- K151409Selectra Catheters and Selectra Accessory Kit2Cleared 510(K)
- K150865Metacross RX PTA Balloon Dilitation Catheter2Cleared 510(K)
- K150107Arc Intracranial Support Catheter, Arc Mini Intracranial Support Catheter2Cleared 510(K)
- K151103ASAHI Corsair Microcatheter2Cleared 510(K)
- K151082MicroCross Catheter2Cleared 510(K)
- K150970Coda LP Balloon Catheter2Cleared 510(K)
- K143608NovaCross Microcatheter2Cleared 510(K)
- K143744MicroCross Catheter2Cleared 510(K)
- K143459Silk Road Acccess Catheter2Cleared 510(K)
- K150366SOFIA 6F Catheter2Cleared 510(K)
- K142449Headway 27 Microcatheter2Cleared 510(K)
- K141981ASAHI FUBUKI 043 / ASAHI FUBUKI2Cleared 510(K)
- K150201Quick-Cross Extreme Support Catheter, Quick-Cross Select Support Catheter2Cleared 510(K)
- K141354NAVAJO PTA BALLOON DILATATION CATHETER2Cleared 510(K)
- K142321Benchmark Intracranial Access System2Cleared 510(K)
- K143412ADROIT Guiding Catheter2Cleared 510(K)
- K142239CPS Direct MediGuide Enabled outer catheter2Cleared 510(K)
- K142235CPS Aim MediGuide Enabled inner catheter, CPS Aim Mediguide Enabled inner Catheter2Cleared 510(K)
- K141529ALVIGUIDE BLUE+ INTERVENTIONAL CARDIOLOGY GUIDING CATHETER2Cleared 510(K)
- K142065TURNPIKE CATHETER2Cleared 510(K)
- K140910CENTERCROSS CATHETER2Cleared 510(K)
- K142565Excelsior XT-17 Microcatheter, Excelsior XT-17 Flex Microcatheter, Excelsior XT-17 Pre-Shaped Microcatheter, Excelsior XT-17 Flex Pre-Shaped Microcatheter2Cleared 510(K)
- K141649SPEX SUPPORT CATHETER2Cleared 510(K)
- K142014SOFIA DISTAL ACCESS CATHETER2Cleared 510(K)
- K141547WINGMAN EXTENDABLE TIP SUPPORT CATHETER2Cleared 510(K)
- K140557MIVI 6F GUIDE CATHETER2Cleared 510(K)
- K140080ENVOY DISTAL ACCESS (DA) GUIDING CATHETER, 6F, 95CM & 105CM, STRAIGHT & XB, MPD & XB, MPC & XB2Cleared 510(K)
- K140307ENVOY GUIDING CATHETER2Cleared 510(K)
- K132914ACUITY PRO LEAD DELIVERY SYSTEM2Cleared 510(K)
- K133539TOTAL ACROSS2Cleared 510(K)
- K140034SUREFIRE GUIDING CATHETER2Cleared 510(K)
- K133501LEADLINER CS LEAD DELIVERY SYSTEM2Cleared 510(K)
- K133177MODIFIED HD GUIDE CATHETER2Cleared 510(K)
- K131592ENLIGHTN RENAL GUIDE CATHETER2Cleared 510(K)
- K131204ADVANCE CS CORONARY SINUS INFUSION CATHETER2Cleared 510(K)
- K133026UNBALLOON NON-OCCLUSION MODELING CATHETER2Cleared 510(K)
- K132652VIA MICROCATHETER, VIA PLUS MICROCATHETER2Cleared 510(K)
- K131482SOFIA DISTAL ACCESS CATHETER2Cleared 510(K)
- K132542TRANSGATE GUIDE CATHETER2Cleared 510(K)
- K130649SILK ROAD ACCESS CATHETER2Cleared 510(K)
- K132556SHEATHLESS EAUCATH CORONARY GUIDE CATHETER2Cleared 510(K)
- K1326735F & 6F LAUNCHER GUIDE CATHETER, 5F SHERPA ACTIVE NX GUIDE CATHETER, 6F Z4 GUIDING CATHETER2Cleared 510(K)
- K130378RESPIGUIDE DELIVERY SYSTEM2Cleared 510(K)
- K130858REVERSE MEDICAL MICROCATHETER2Cleared 510(K)
- K131492MODIFIED FLOWGATE BALLOON GUIDE CATHETER2Cleared 510(K)
- K130525OCCLUSION PERFUSION CATHETER2Cleared 510(K)
- K132659VOLCANO PREVIEW FORWARD-LOOKING IVUS SYSTEM2Cleared 510(K)
- K132701PRIMI SUPPORT CATHETER2Cleared 510(K)
- K132420WINGMAN EXTENDABLE TIP SUPPORT CATHETER2Cleared 510(K)
- K132409CONCIERGE GUIDING CATHETER2Cleared 510(K)
- K131978SELECTRA ACCESSORY KIT, SELECTRA SLITTER TOOL2Cleared 510(K)
- K130714PROGIGY SUPPORT CATHETER2Cleared 510(K)
- K131063AMPLATZER TORQ VUE LP DELIVERY SYSTEM2Cleared 510(K)
- K132197CONVEY 7F GUIDING CATHETER, CONVEY 8F GUIDING CATHETER2Cleared 510(K)
- K131493SIDEKICK AND USHER SUPPORT CATHETERS2Cleared 510(K)
- K122917CODA BALLOON CATHETER2Cleared 510(K)
- K130850PRIMI AND SECONDI SUPPORT CATHETERS2Cleared 510(K)
- K131225ADROIT GUIDING CATHETER2Cleared 510(K)
- K122826PREVIEW FORWARD-LOOKING IVUS CATHETER AND LAPTOP SYSTEM; PREVIEW CATHETER MODEL 87000; PIMF MODEL 87-PIMF; LAPTOP SYSTEM2Cleared 510(K)
- K123153ATTAIN COMMAND+SUREVALVE LEFT HEART DELIVERY SYSTEM ATTAIN COMMAND GUIDE CATHETERS FOR LEFT HEART DELIVERY,ATTAIN SELECT2Cleared 510(K)
- K130252CPS AIM UNIVERSAL SLITTABLE INNER CATHETER2Cleared 510(K)
- K130257CPS DIRECT UNIVERSAL SLITTABLE OUTER CATHETER2Cleared 510(K)
- K123765GUIDEZILLA GUIDE EXTENSION CATHETER2Cleared 510(K)
- K122940ADVANCE MICRO 14 ULTRA LOW PROFILE BALLOON DILATATION CATHETER MODEL PTA32Cleared 510(K)
- K123311QXMEDICAL ACCESS & SUPPORT CATHETER2Cleared 510(K)
- K123324SELECTRA 7F CATHETERS2Cleared 510(K)
- K123452TRACKER-17 MICROCATHER, 150 CM LONG AND 15.0 CM FLEXIBLE DISTAL SHAFT, TRACKER-17 MICROCATHETER, 150 CM LONG AND 7.5 CM2Cleared 510(K)
- K121077NHANCER2Cleared 510(K)
- K123531UNBALLOON NON-OCCLUSIVE MODELING CATHETER2Cleared 510(K)
- K122684REVERSE MEDICAL MICROCATHETER2Cleared 510(K)
- K121763MULTICROSS SUPPORT CATHETER2Cleared 510(K)
- K122581MODIFIED BALLOON GUIDE CATHETER MODEL 90253, 902542Cleared 510(K)
- K122772PENUMBRA DDC CATHETERS2Cleared 510(K)
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- K042538SAILOR PLUS PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER, MODEL SAEXXXXXXXXX2Cleared 510(K)
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- K032069WORKHORSE II PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY BALLOON CATHETER2Cleared 510(K)
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- K031459RAPIDO CUT-AWAY CUTTER2Cleared 510(K)
- K031211ATTAIN PREVAIL STEERABLE CATHETER SET, MODEL 6228CTH2Cleared 510(K)
- K031417ILT SAFE CROSS 0.035 SUPPORT CATHETER, MODEL C135SN12Cleared 510(K)
- K031766ATB ALL-TERRAIN BALLOON PTA DILATATION CATHETER2Cleared 510(K)
- K031505RAPIDO CUT-AWAY GUIDING CATHETER2Cleared 510(K)
- K030589MODIFICATION TO NUMED TYSHAK II AND Z-MED II PTV CATHETERS2Cleared 510(K)
- K030984SAFE CROSS ANGLED SUPPORT 0.14, SAFE CROSS STRAIGHT SUPPORT CATHETER 0.14, SAFE CROSS ANGLED SUPPORT CATHETER, SAFE CROT2Cleared 510(K)
- K0307795F MEDTRONIC LAUNCHER GUIDE CATHETER2Cleared 510(K)
- K030715SAFFRON NM GUIDING CATHETER2Cleared 510(K)
- K021802STEREOTAXIS CATHETER ADVANCER SYSTEM2Cleared 510(K)
- K024327SETPOINT ENDOVASCULAR TEMPERATURE PROBE2Cleared 510(K)
- K030476MODIFIED CONCENTRIC RETRIEVER, MODEL 900372Cleared 510(K)
- K023463CVSI PERIPHERAL BALLOON CATHETER; CVSI CATHETER INFLATION UNIT2Cleared 510(K)
- K024032ATTAIN 6216A-MP MULTI-PURPOSE GUIDE CATHETER FOR LEFT-HEART DELIVERY2Cleared 510(K)
- K024035ATTAIN 6218A-AM AMPLATZ GUIDE CATHETER FOR LEFT-HEART DELIVERY2Cleared 510(K)
- K023320AGILTRAC .035 PERIPHERAL DILATATION CATHETER2Cleared 510(K)
- K0234028F LAUNCHER GUIDE CATHETER2Cleared 510(K)
- K023223MODIFICATION TO LUMEND FRONTRUNNER CTO CATHETER2Cleared 510(K)
- K022552ATB ALL-TERRAIN BALLOON PTA DILATATION CATHETER2Cleared 510(K)
- K022138SPECTRANETICS 0.035 SUPPORT CATHETER, MODEL 518-0282Cleared 510(K)
- K022061CVSI PERIPHERAL BALLOON CATHETER; CVSI INFLATER2Cleared 510(K)
- K022738AGILTRAC .035 PERIPHERAL DILATATION CATHETER2Cleared 510(K)
- K022722PTA AND PTV2Cleared 510(K)
- K0227647F LAUNCHER GUIDE CATHETER2Cleared 510(K)
- K021735BOSTON SCIENTIFIC ULTRA-SOFT SV BALLOON DILATATION CATHETER2Cleared 510(K)
- K021455RAPIDO GUIDING CATHETER, 6F MODEL# 6776; RAPIDO GUIDING CATHETER, 8F MODEL# 6775, 6777, 6778, 6779, 6780, 6781, 6782,2Cleared 510(K)
- K021899CONCENTRIC BALLOON GUIDE CATHETER, MODEL 900722Cleared 510(K)
- K021721EQUALIZER BALLOON CATHETER2Cleared 510(K)
- K021593MODIFICATION TO ENVOY AND VISTA BRITE TIP2Cleared 510(K)
- K021589ATTAIN ACCESS 6218A LEFT-HEART DELIVERY SYSTEM, MODEL 62182Cleared 510(K)
- K021587ATTAIN LDS 6216A LEFT-HEART DELIVERY SYSTEM, MODEL 6216A2Cleared 510(K)
- K021256Z3 GUIDE CATHETER2Cleared 510(K)
- K021284EASYTRAK GUIDING CATHETER2Cleared 510(K)
- K021120RADIAL ARTERY CATHERIZATION SET WITH INTEGRAL NEEDLE PROTECTION,MODEL RA-04020-SP2Cleared 510(K)
- K021088JOGUIDE CARDIOVASCULAR GUIDING C ATHETER2Cleared 510(K)
- K01351710600 DEFLECTABLE CATHETER SYSTEM, MODEL 106002Cleared 510(K)
- K013963MODEL 9210 DELIVERY CATHETER, MODEL 92102Cleared 510(K)
- K020161AGILTRAC .018 PERIPHERAL DILATATION CATHETER2Cleared 510(K)
- K013284LUMEND FRONTRUNNER CTO CORONARY CATHETER2Cleared 510(K)
- K0200286F MACH1/34356-XXX; 5F MACH1/35845-XXX; 7F MACH1/34357-XXX; 8F MACH1/34358-XXX2Cleared 510(K)
- K014212BARD CONQUEST PTA BALLOON DILATATION CATHETER2Cleared 510(K)
- K011562LUMEND PERCUTANEOUS CATHETER2Cleared 510(K)
- K014118MODIFICATION TO SUPERCROSS CATHETER2Cleared 510(K)
- K014117MODIFICATION TO OUTBACK CATHETER2Cleared 510(K)
- K013601NUMED MULLINS PTA CATHETER2Cleared 510(K)
- K011889ULTRA -THIN SDS BALLOON DILATATION CATHETER2Cleared 510(K)
- K013789EXCELSIOR SL-10 MICROCATHETER, MODELS 168581, 168381, 168181, 1681892Cleared 510(K)
- K013638MODIFICATION TO VIKING OPTIMA GUIDING CATHETER2Cleared 510(K)
- K013581CORDIS AVIATOR PERIPHERAL DILATATION CATHETER2Cleared 510(K)
- K010579STENT SUPPORT GUIDE CATHETER2Cleared 510(K)
- K010954CONCENTRIC BALLOON GUIDE CATHETER, MODEL 900312Cleared 510(K)
- K012913BARD UTAVERSE SMALL VESSEL PTA BALLOON DILATATION CATHETER2Cleared 510(K)
- K012050VIATRAC 14 PLUS PERIPHERAL DILATATION CATHETER2Cleared 510(K)
- K012169ILT SUPPORT CATHETER .014, MODEL C114LW1; ILT SUPPORT CATHETER ADVANCING MECHANISM, MODEL A11AM12Cleared 510(K)
- K012130ATTAIN LDS 6216 LEFT-HEART DELIVERY SYSTEM2Cleared 510(K)
- K012083ATTAIN ACCESS 6218 LEFT-HEART DELIVERY SYSTEM, MODEL 62182Cleared 510(K)
- K012002VIKING OPTIMA GUIDING CATHETER2Cleared 510(K)
- K0108746F MACH 1, MODEL 34356-XXX2Cleared 510(K)
- K010838FOX PTA CATHETER, 3.0, 4.0, 5.0, 6.0, 7.0, AND 8.0 X 40 MM, MODELS A14003, A14004, A14005, A14006, A14007, A140082Cleared 510(K)
- K003920CORDIS M3 PTA DILATATION CATHETER2Cleared 510(K)
- K011464RX VIATRAC 14 PERIPHERAL DILATATION CATHETER, OTW VIATRAC 18 PERIPHERAL DILATATION CATHETER, RX HERCULINK 14 BILIARY STN2Cleared 510(K)
- K010831AVIATOR PERIPHERAL DILATATION CATHETER2Cleared 510(K)
- K003410CONCENTRIC RETRIEVER, MODEL 900302Cleared 510(K)
- K003880CONCENTROC HD GUIDE CATHETER, MODELS 90017 (4F), 90019 (5F), 90021 (6F), 90022 (7F), 90023 (8F), 90024 (9F)2Cleared 510(K)
- K001694GUIDANT RETRIEVER DEVICE2Cleared 510(K)
- K010880NUMED HIGH PRESSURE PTA CATHETERS2Cleared 510(K)
- K010853GUIDER SOFTIP GUIDING CATHETER XF 5F2Cleared 510(K)
- K010531ILT DEFLECTING CATHETER, MODEL C114ND12Cleared 510(K)
- K003085CONCENTRIC GUIDE CATHETER, MODELS 90018, 900202Cleared 510(K)
- K001856SUPERCROSS CATHETER2Cleared 510(K)
- K010169BARD UTRAVERSE SMALL VESSEL PTA BALLOON DILATATION CATHETER2Cleared 510(K)
- K003495ANCURE LLIAC BALLOON CATHETER2Cleared 510(K)
- K001577OUTBACK CATHETER2Cleared 510(K)
- K003643NUMED Z-MED PTV CATHERERS2Cleared 510(K)
- K001992ILT 0.014 CATHETER, MODEL C114NL22Cleared 510(K)
- K001969GT2 FUSION GUIDE WIRE, MODEL NTLHLJ180,NTLHLS180, NTLHLJ300, NTLHLS3002Cleared 510(K)
- K001435VIKING OPTIMA GUIDING CATHETER2Cleared 510(K)
- K001136CORDIS INTRODUCER GUIDE2Cleared 510(K)
- K000715ENVOY AND VISTA BRITE TIP2Cleared 510(K)
- K000677ZUMA GUIDE CATHETERS2Cleared 510(K)
- K0005985F GUIDING CATHETER2Cleared 510(K)
- K994229VERIPATH PERIPHERAL GUIDING CATHETER2Cleared 510(K)
- K991059SPECTRANETICS 0.014 SUPPORT CATHETER, MODEL 518-016, SPECTRANETICS 0.018 SUPPORT CATHETER, MODEL 518-0172Cleared 510(K)
- K991601DUAL LUMEN CATHETER, MODEL DL-35-902Cleared 510(K)
- K992673VISTA BRITE TIP CATHETERS2Cleared 510(K)
- K992622INTRAMAX ITI GUIDE CATHETER2Cleared 510(K)
- K984482AVE GL-1 GUIDING CATHETER2Cleared 510(K)
- K974683NAVIPORT DEFLECTABLE TIP GUIDING CATHETER2Cleared 510(K)
- K981191ITI INTRAMAX GUIDE CATHETER 91, 78 AND 652Cleared 510(K)
- K990726ENVY GUIDING CATHETER2Cleared 510(K)
- K990707MEDTRONIC 5F & 9F ZUMA GUIDING CATHETERS2Cleared 510(K)
- K981359GT LEGGIERO2Cleared 510(K)
- K972065AURORA2Cleared 510(K)
- K980278URESIL VASCU-FLO INFUSION CATHETER2Cleared 510(K)
- K982883MEDTRONIC 7F AND 8F ZUMA GUIDING CATHETER2Cleared 510(K)
- K982632ENVOY AND VISTA BRITE TIP2Cleared 510(K)
- K9827706F ENVOY GUIDING CATHETER2Cleared 510(K)
- K980453SCHNEIDER GUIDER SOFTIP GUIDING CATHETERS2Cleared 510(K)
- K981198MEDTRONIC ZUMA GUIDING CATHETER2Cleared 510(K)
- K973298CARDIMA VUEPORT CORONARY SINUS BALLOON OCCLUSION GUIDING CATHETER2Cleared 510(K)
- K970668THE AMPLANTZ GOOSE NECK MICROSNARE2Cleared 510(K)
- K981413SCHNEIDER GUIDER SOFTIP GUIDING CATHETERS2Cleared 510(K)
- K974684SCIMED 7 FRENCH WISEGUIDE GUIDE CATHETER2Cleared 510(K)
- K973371CERTODYN RAECG UNIVERSAL ADAPTER2Cleared 510(K)
- K972978VISTA BRITE TIP GUIDING CATHETERS2Cleared 510(K)
- K972484ACS VIKING GUIDING CATHETER2Cleared 510(K)
- K970401MEDI-DYNE GUIDING CATHETER2Cleared 510(K)
- K965247ENVOY GUIDING CATHETER2Cleared 510(K)
- K971572VISTA BRITE TIP CATHETERS2Cleared 510(K)
- K970823SCIMED 8 FRENCH WISEGUIDE GUIDE CATHETER2Cleared 510(K)
- K963962VISTA BRITE TIP CATHETERS2Cleared 510(K)
- K965211VISTA BRITE TIP CATHETERS2Cleared 510(K)
- K9627176 FRENCH, 7 FRENCH, AND 8 FRENCH GUIDING CATHETERS WITH PHOSPHORYLCHOLINE (PC) POLYMER COATING2Cleared 510(K)
- K96366311F GUIDING CATHETER2Cleared 510(K)
- K962830VISTA BRITE TIP CATHETERS2Cleared 510(K)
- K962362CORDIS ENVOY & VISTA BRITE TIP GUIDING CATHETERS2Cleared 510(K)
- K961280SCIMED 6-10 F TRIGUIDE GUIDE CATHETERS 6F,7F,8F,9F & 10F2Cleared 510(K)
- K955651MEDTRONIC SHERPA GUIDING CATHETER2Cleared 510(K)
- K953265SCIMED ANGIOGRAPHIC KITS2Cleared 510(K)
- K953987ACS TOURGIDE GUIDING CATHETER2Cleared 510(K)
- K950490MEDTRONIC GC IV CORONARY GUIDING CATHETER2Cleared 510(K)
- K953909SCIMED 6 FRENCH MICRO-MAX GUIDE CATHETER2Cleared 510(K)
- K9542515F ENVOY GUIDING CATHETER (MODIFICATION)2Cleared 510(K)
- K951603CARDIMA, INC. FORERUNNER2Cleared 510(K)
- K951159FASGUIDE2Cleared 510(K)
- K953515SCIMED TRIGUIDE GUIDE CATHETERS2Cleared 510(K)
- K952345MEDI-TECH PLATFORM GUIDE CATHETER2Cleared 510(K)
- K952205ACS POWERBASE GUILDING CATHETER2Cleared 510(K)
- K952185CORDIS BRITE TIP, ENVOY GUIDING CATHETER2Cleared 510(K)
- K950179MEDTRONIC(R) GC III CORONARY GUIDING CATHETER2Cleared 510(K)
- K946272SCIMED(R) COURIER GUIDE CATHETER2Cleared 510(K)
- K950047SCHNEIDER GEX(TM) .014/.018 GUIDEWIRE EXCHANGE CATHETER2Cleared 510(K)
- K950026MEDTRONIC(R) 8.2 FRENCH SHERPA(R) SUPER PEAK FLOW(TM) CORONARY GUIDING CATHETER2Cleared 510(K)
- K946204SCIMED(R) TRIDUIGE(R) GUIDE CATHETERS2Cleared 510(K)
- K950094SCIMED 6 FRENCH MICRO-MAX(TM) GUIDE CATHETER2Cleared 510(K)
- K944668SHERPA SHERPA II AND ASCENT CORONARY GUIDING CATHETERS2Cleared 510(K)
- K950635CANDEKA DUKATIR SETS2Cleared 510(K)
- K950634CANDELA SHEATH SETS2Cleared 510(K)
- K9457055F ENVOY(TM) GUIDING CATHETER2Cleared 510(K)
- K943622SCHNEIDER PINK POWER SOFTIP GUIDNIG CATHETER2Cleared 510(K)
- K944537SCIMED TRIGUIDE GUIDE CATHETER2Cleared 510(K)
- K935597FASGUIDE CATHETER2Cleared 510(K)
- K9437837 FRENCH LARGE LUMEN TRIGUIDE-PLUS2Cleared 510(K)
- K943777SCIMED 8 FRENCH BIG-MAX GUIDE CATHETER2Cleared 510(K)
- K941137SCIMED TRIGUIDE GUIDING CATHETER2Cleared 510(K)
- K935292SCHNEIDER GUIDEZILLA SOFTIP GUIDING CATHETER2Cleared 510(K)
- K940545SCIMED 10 FR LARGE LUMEN TRIGUIDE-FLEX GUID CATH2Cleared 510(K)
- K935738MEDTRONIC GCIII CORONARY GUIDING CATHETER2Cleared 510(K)
- K940559ACS POWERBASE(TM) CORONARY GUIDING CATHETER2Cleared 510(K)
- K935425METRONIC BUCHBINDER ENVOY PERCUTANEOUS CATHETERS2Cleared 510(K)
- K940603SCIMED 8 FRENCH TRIGUIDE GUIDING CATHETER2Cleared 510(K)
- K934685SOFTTOUCH GUIDE CATHETER2Cleared 510(K)
- K940187ENVOY GUIDING CATHETER2Cleared 510(K)
- K930476GUIDING CATHETER2Cleared 510(K)
- K932933GC IV CORONARY GUIDING CATHETER2Cleared 510(K)
- K9349889 FRENCH LARGE LUMEN TRIGUIDE PLUS GUIDING CATHETER2Cleared 510(K)
- K934009ACS POWERGUIDE CORONARY GUIDING CATHETER2Cleared 510(K)
- K933019USCI SUPER 6 6F PTCA GUIDING CATHETER2Cleared 510(K)
- K925439MICROSNARE2Cleared 510(K)
- K933033GUIDING CATHETER HEMOSTASIS VALVE CAP2Cleared 510(K)
- K932619TRANSSEPTAL INTRODUCER SET2Cleared 510(K)
- K931403SITERITE NEEDLE GUIDE (MODIFIED)2Cleared 510(K)
- K925131CORDIS 9 F GUIDING CATHETER2Cleared 510(K)
- K922609ITC CATHETERS W/ HYDROMER2Cleared 510(K)
- K926421ACS ET HI-FLOW/ENHANCED TORQUE CORONARY GUID CATH2Cleared 510(K)
- K923245TRIGUIDE-PLUS GUIDING CATHETER2Cleared 510(K)
- K923518GUIDING CATHETER2Cleared 510(K)
- K922611SCIMED 6 FR. TRIGUIDE - ELITE GUIDING CATHETER2Cleared 510(K)
- K924591SCHNEIDER SOLID-7 SOPTIP GUIDING CATHETER2Cleared 510(K)
- K921311CORDIS SHUTTLE CATHETER W/ SIDEHOLES2Cleared 510(K)
- K914984E-Z-FLOW ANGIOGRAPHY CATHETERS, MODIFICATION2Cleared 510(K)
- K914856VASCULAR CATHETER & WIRE GUIDES W/MEDI-COAT(TM)2Cleared 510(K)
- K920331RIGHT ATRIAL CATHETER KITS2Cleared 510(K)
- K915521TRACKER(R) UNIBODY CATH & TRACKER 25 CATH,MODIFIED2Cleared 510(K)
- K915374CORDIS 6 FRENCH 0.062 I.D. PTCA GUIDING CATHTER2Cleared 510(K)
- K915777CORDIS SHUTTLE CATHETER2Cleared 510(K)
- K914422DEVICES FOR VASCU INTERVENT ROTAT HEMOSTAT VALVE2Cleared 510(K)
- K913830SCIMED 8 FR. TRIGUIDEFLEX GUIDING CATHETERS2Cleared 510(K)
- K913052ITC GUIDING CATHETER2Cleared 510(K)
- K913517ISOLATE INFUSION CATHETR SYSTEM2Cleared 510(K)
- K913783CORDIS PTCA GUIDING CATHETER, MODIFICATION2Cleared 510(K)
- K911869IVT GUIDING CATHETER2Cleared 510(K)
- K912877PROFUSE INFUSION SYSTEM2Cleared 510(K)
- K911333RIGHT ATRIAL CATHETERS2Cleared 510(K)
- K912777CORDIS 7 FRENCH 0.072 I.D. PTCA GUIDING CATHETER2Cleared 510(K)
- K911747PRO-GUIDE2Cleared 510(K)
- K912564MEGA PERICARDIOCENTESIS KIT2Cleared 510(K)
- K912199SOFTTOUCH(R) GUIDING CATHETER2Cleared 510(K)
- K912191SOFTOUCH(R) GUIDING CATHETER W/BUMPER TIP2Cleared 510(K)
- K910116TURBO SUPPORT CATHETER2Cleared 510(K)
- K911519CATHCAP, CAT. NO. CC100 SERIES2Cleared 510(K)
- K911527NOVOSTE GUIDING CATHETER2Cleared 510(K)
- K905249NEW USCI 7F PTCA GUIDING CATHETER2Cleared 510(K)
- K904404MULTI-LUMEN CENTRAL VENOUS CATHETER SET2Cleared 510(K)
- K902256IRRIGATION CATHETER 4, 6 AND 10 FRENCH2Cleared 510(K)
- K905720PALMAZ BILIARY STENT2Cleared 510(K)
- K905547SOFTOUCH GUIDING CATHETER2Cleared 510(K)
- K902999VASCULAR RETRIEVAL FORCEPS2Cleared 510(K)
- K904884ACS URETHAN CORONARY GUIDING CATHETER2Cleared 510(K)
- K904608PERCUTANEOUS INTRODUCER TRAY2Cleared 510(K)
- K902587SCHNEIDER MONORAIL-GEX(TM) GUIDEWIRE EXCHANGE CATH2Cleared 510(K)
- K903330MALLINCKRODT MEDICAL, INC., INFUSSION CATHERTER2Cleared 510(K)
- K903217TAPERED TIP THE GUIDER CORONARY GUIDING CATHETER2Cleared 510(K)
- K903216THE GUIDER CORONARY GUIDING CATHETER2Cleared 510(K)
- K903158SITERITE NEEDLE GUIDE2Cleared 510(K)
- K902905COOK CORONARY GUIDING CATHETER2Cleared 510(K)
- K900978MANAN ARTERIAL CATHETER NEEDLE2Cleared 510(K)
- K900998INTERVENTIONAL MEDICAL Y ADAPTER W/ADJUST. VALVE2Cleared 510(K)
- K900657UNIVERSAL DELIVERY SYSTEM CATHETER2Cleared 510(K)
- K895972CURITY(R) PERCUTANEOUS CATHETERS2Cleared 510(K)
- K897082SCHNEIDER SIDEKICK MONORAIL Y-CONNECTOR2Cleared 510(K)
- K895932PSG(TM) EDM(TM) INFUSION CATHETER2Cleared 510(K)
- K895440QUINTON MAHURKAR CATHETERS W/VITACUFF2Cleared 510(K)
- K895753BREVET DISPOSABLE CONNECTORS2Cleared 510(K)
- K894105TARGET THERAPEUTICS TRACKER LF CATHETER2Cleared 510(K)
- K894131DERMAPORT VASCULAR ACCESS DEVICE MODEL NO. 50-10002Cleared 510(K)
- K894682USCI UNCOATED GUIDING CATHETERS2Cleared 510(K)
- K894084TARGET CATHETERS AND GUIDE WIRES FOR PEDIATRIC USE2Cleared 510(K)
- K890152USCI PROBING CATHETER2Cleared 510(K)
- K891069USCI CORONARY INFUSION CATHETER2Cleared 510(K)
- K884491MEDIZIV CENTRAL VEIN CATHETER2Cleared 510(K)
- K885237ACS SELECTIVE INFUSION CATHETER2Cleared 510(K)
- K884209USCI DORROS INFUSION/PROBING CATHETER2Cleared 510(K)
- K884129BIO-MEDICUS PERCUTANEOUS CANNULA & INTRODUCER SET2Cleared 510(K)
- K883564ACS SOFT-TIP CORONARY INFUSION CATH W/SIDE HOLES2Cleared 510(K)
- K883916ROTATING HEMOSTATIC VALVE2Cleared 510(K)
- K881793WILSON BIOMEDICAL CORONARY GUIDING CATHETER2Cleared 510(K)
- K883174MULTI-MED INFUSION CATHETER AND KIT DOUBLE/TRIPLE2Cleared 510(K)
- K882969VASCULAR ACCESS PORT/CATHETER NO.VP-XXX VASPORT2Cleared 510(K)
- K882803ET HI-FLOW SOFT TIP/ET HI-FLOW/ENHANCED TORQUE ST2Cleared 510(K)
- K881504VEN-A-CATH PERCUTANEOUS VENOUS CATHETER KIT2Cleared 510(K)
- K874874ACS HI-TORQUE CORONARY GUIDING CATHETER W/SOFT TIP2Cleared 510(K)
- K875269ACS SOFT-TIP CORONARY INFUSION CATHETER W/SIDEHOLE2Cleared 510(K)
- K874751TRACKER-25 INFUSION CATHETER2Cleared 510(K)
- K873485EDSLAB (R) OCCLUSION BALLOON CATHETER2Cleared 510(K)
- K872182POLYSTAN WIRE REINFORCED CATHETERS AND CANNULAE2Cleared 510(K)
- K872163IMPRA DUAL LUMEN SUBCLAVIAN CATHETER2Cleared 510(K)
- K873035VASCULAR ACCESS PORT/CATH CAT. #VP-XXX VASPORT SER2Cleared 510(K)
- K871573CENTRAL VENOUS MULTI-LUMEN CATHETERS AND KITS2Cleared 510(K)
- K871080PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER2Cleared 510(K)
- K863791SUBCLAVIAN, GISH MODEL NO. SVAC-XXXX2Cleared 510(K)
- K863790J-CATH, GISH MODEL NO. JVAC-XXXX2Cleared 510(K)
- K870411CENTRAL VEIN CATHERIZATION KIT W/WITHOUT MEDICA.2Cleared 510(K)
- K870412TRIPLE LUMEN INFUSION CATHETERIZATION SET OR KIT2Cleared 510(K)
- K871425ACS ENHANCED-TORQUE CORONARY GUIDING CATHETER2Cleared 510(K)
- K865074CORDAY CORONARY SINUS INFUSION CATHETER2Cleared 510(K)
- K870067MULTICATH - CODE#S 8.1207.OO/8.1208.00/8.1205.202Cleared 510(K)
- K870075CENTRAL VENOUS CATHETER2Cleared 510(K)
- K870675ADDITIONAL 13.4CM. FRENCH CATHETER INSERTION TRAY2Cleared 510(K)
- K864118MEDI-TECH SELECTIVE TORQUE CATHETER2Cleared 510(K)
- K863916CVI 16 GAUGE CENTRAL VEIN CATHERIZATION SYSTEM2Cleared 510(K)
- K863684URESIL SUBCLAVIAN CATHETER2Cleared 510(K)
- K862724VEIN VALVE CUTTER2Cleared 510(K)
- K863564URESIL IRRIGATION CATHETER2Cleared 510(K)
- K862117TRACKER INFUSION CATHETER2Cleared 510(K)
- K862975MODIFIED PTCA GUIDING CATHETERS2Cleared 510(K)
- K863322MODIFIED MAHURKAR SUBCLAVIAN & FEMORAL CATHETERS2Cleared 510(K)
- K862056[CENTRAL VENOUS][MULTI-LUMEN] CATHETER W/FLEX TIP2Cleared 510(K)
- K861827CURITY CENTRAL VENOUS CATHETERIZATION TRAY2Cleared 510(K)
- K861828CURITY VENOUS CATHETERIZATION KIT2Cleared 510(K)
- K861829CURITY CENTRAL VENOUS CATHETER2Cleared 510(K)
- K854610VASCULAR ACCESS PORT/CATH CAT.#VP-XXXX VASPORT SER2Cleared 510(K)
- K861165PHARMASEAL DUAL LUMEN CATHETER2Cleared 510(K)
- K861008PERCUTANEOUS CATHETERS2Cleared 510(K)
- K855201BARD PARKER PERFUSION CATHETER2Cleared 510(K)
- K860699RIGHT ATRIAL CATHETER CATALOG NO. RAC - XXX SERIES2Cleared 510(K)
- K860339PERCUTANEOUS CATHETERS2Cleared 510(K)
- K854984CUP MONITORING KIT CVPK-142Cleared 510(K)
- K851241GRECO-HARVEY SURFACTANT BONDED CATHETER FOR CARDIO2Cleared 510(K)
- K853714PHARMASEAL OVER-THE NEEDLE ARTERIAL CATHETER & STA2Cleared 510(K)
- K854137ARROW BRACHIAL CENTRAL VENOUS CATH-KIT W/16GA & EC2Cleared 510(K)
- K853998GUIDING CATHETER2Cleared 510(K)
- K854000INFUSION CATHETER W/SIDE HOLES2Cleared 510(K)
- K853997INFUSION CATHETER2Cleared 510(K)
- K8527917 FRENCH DUAL LUMEN COM CENT VEIN CATH SYS2Cleared 510(K)
- K853860REPAIR KIT QUINTON TRIPLE LUMEN RIGHT ATRIAL CATHE2Cleared 510(K)
- K852914ANGIOGRAPHIC, WEDGE PRESS, DUAL THERMOD & INFUSION2Cleared 510(K)
- K852491AMERICAN PHARMASEAL TRIPLE LUMEN CATHETER2Cleared 510(K)
- K852815TRIPLE LUMEN RIGHT ATRIAL CATHETER2Cleared 510(K)
- K852388MAHURKAR SUBCLAVIAN CATHETER INSERTION KIT2Cleared 510(K)
- K852099BARD-PARKER IRRIGATION CATHETER2Cleared 510(K)
- K850829WIRE, GUIDE, CATHETER2Cleared 510(K)
- K850353CORONARY INFUSION CATHETER W/SIDEHOLES2Cleared 510(K)
- K843263ARROW-JOHANS ECG ADAPTOR2Cleared 510(K)
- K842645CARDIAC SUPPLY TRAY2Cleared 510(K)
- K841797MULTIPRO CATHETER2Cleared 510(K)
- K842084AXIOM FEMORAL VENUS CATHETER2Cleared 510(K)
- K842316CRITIKON TRIPLE-LUMEN CENTRAL VENOUS2Cleared 510(K)
- K842176RAAF DUAL LUMEN CATHETER2Cleared 510(K)
- K841828CENTRAL VENOUS CATHETER W/BIG-GARD2Cleared 510(K)
- K840762SILVERTORQUE CEREBRAL CATHETER2Cleared 510(K)
- K841587CENTRAL VENOUS ACCESS CATHETER CVAC-XX2Cleared 510(K)
- K840761SILVERTORQUE VISCERAL CATHETER2Cleared 510(K)
- K833873CARDIOSEARCH RIGHT ATRIAL CATH-2Cleared 510(K)
- K834232VAS-CATH DSA CATHETER/TRAY2Cleared 510(K)
- K840240MICROFUSE INTRAVENOUS CATHETER SET2Cleared 510(K)
- K833801RIGHT CORONARY GUIDING CATHETER2Cleared 510(K)
- K840336RADIOPAQUE 7 FRX 12-POLYURETHANE MULTI2Cleared 510(K)
- K840175DOUBLE LUMEN INFUSION CATHETERS2Cleared 510(K)
- K834109MAHURKAR DUAL LIMEN FEMORAL CATHETER2Cleared 510(K)
- K833573CENTRAL VEIN CATH. TRAY CC-20-14202Cleared 510(K)
- K833825MULTI-LUMEN INTRAVENOUS INFUSION CATH2Cleared 510(K)
- K833433PHYSIO-PROBE-HIGH PERMEABILITY CATH.2Cleared 510(K)
- K833303DUOFLO 6F2Cleared 510(K)
- K832784ULTRA LIGHT RAAF CATHETER2Cleared 510(K)
- K831636PERCUTANEOUS INTRODUCER KIT2Cleared 510(K)
- K832178AMPLATZ HEPARIN COATED CATHETER2Cleared 510(K)
- K832064VENOUS CATHETER2Cleared 510(K)
- K831807CATHETER INSERTION TRAYS, VARIOUS #'S2Cleared 510(K)
- K831729PERCUTANEOUS CATHETER INSERTION TRAY2Cleared 510(K)
- K831717CORONARY INFUSION CATHETER2Cleared 510(K)
- K831563CORONARY GUIDING CATHETER-MODIFIED2Cleared 510(K)
- K822393INTRAOPERATIVE BALLOON DILATION CATH.2Cleared 510(K)
- K821189MULTIPURPOSE CATHETER2Cleared 510(K)
- K821480RIGHT ATRIAL CATHETERS PARENTERAL NUTRIT2Cleared 510(K)
- K820736CENTRAL VENOUS ACCESS CATHETER2Cleared 510(K)
- K820516ARTERIAL CANALIZATION DEVICE2Cleared 510(K)
- K820648ARROW M.I.S. MULTI-LUMEN CATHETERIZA2Cleared 510(K)
- K820009ARROW JUGULAR PUNCTURE KIT 16 GA.2Cleared 510(K)
- K813514EDSLAB CATHETER COVER2Cleared 510(K)
- K811971CORDIS DUCOR PTR SYSTEM2Cleared 510(K)
- K810962ARROW VESSEL CATHETER. KIT W/20GA INDWEL2Cleared 510(K)
- K810461BURRON CENTRAL VEIN CATHERIZATION KIT2Cleared 510(K)
- K810460BURRON PERCUTANEOUS INDUCER SET2Cleared 510(K)
- K802287RIGHT ATRIAL LINE KIT2Cleared 510(K)
- K790083CATHETER, ARTERIAL LINE2Cleared 510(K)
- DRACatheter, Steerable2Product Code
- DRBStylet, Catheter2Product Code
- DRCTrocar2Product Code
- DREDilator, Vessel, For Percutaneous Catheterization2Product Code
- DRFCatheter, Electrode Recording, Or Probe, Electrode Recording2Product Code
- DSIDetector And Alarm, Arrhythmia2Product Code
- DSJAlarm, Blood-Pressure2Product Code
- DSKComputer, Blood-Pressure2Product Code
- DXGComputer, Diagnostic, Pre-Programmed, Single-Function2Product Code
- DXLInjector, Indicator2Product Code
- DXMDensitometer2Product Code
- DXNSystem, Measurement, Blood-Pressure, Non-Invasive2Product Code
- DXQBlood Pressure Cuff2Product Code
- DXWSystem, Phonocatheter, Intracavitary2Product Code
- DXXSystem, Catheter Control, Steerable2Product Code
- DYBIntroducer, Catheter2Product Code
- DYGCatheter, Flow Directed2Product Code
- JOQGenerator, Pulse, Pacemaker, External Programmable (For Electrophysiological Studies Only)2Product Code
- KRACatheter, Continuous Flush2Product Code
- KRBProbe, Thermodilution2Product Code
- KRKManometer, Blood-Pressure, Venous2Product Code
- LDEStethoscope, Manual1Product Code
- LITCatheter, Angioplasty, Peripheral, Transluminal2Product Code
- MAVSyringe, Balloon Inflation2Product Code
- MHXMonitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)2Product Code
- MLDMonitor, St Segment With Alarm2Product Code
- MTDCatheter, Intracardiac Mapping, High-Density Array2Product Code
- MXDRecorder, Event, Implantable Cardiac, (With Arrhythmia Detection)2Product Code
- NFATemporary Coronary Saphenous Vein Bypass Graft For Embolic Protection2Product Code
- NKQGuidewire, Catheter, Reprocessed2Product Code
- NKRSystem, Catheter Control, Reprocessed2Product Code
- NKSCatheter, Steerable, Reprocessed2Product Code
- NKUInjector And Syringe, Angiographic, Balloon Inflation, Reprocessed2Product Code
- NKWActuator, Syringe, For Injector, Reprocessed2Product Code
- NLGCatheter, Intracardiac Mapping, High-Density, Reprocessed2Product Code
- NLHCatheter, Recording, Electrode, Reprocessed2Product Code
- NLICatheter, Angiography, Reprocessed2Product Code
- NMBCatheter, Oximeter, Fiber Optic, Reprocessed2Product Code
- NMKTrocar, Reprocessed2Product Code
- NMMCatheter, Angioplasty, Peripheral, Transluminal, Reprocessed2Product Code
- NPPReprocessed Blood Pressure Cuff2Product Code
- NTETemporary Carotid Catheter For Embolic Capture2Product Code
- NVMCatheter, Angioplasty, Peripheral, Transluminal, Dual-Balloon2Product Code
- OBICatheter, Pressure Monitoring, Cardiac2Product Code
- OBJCatheter, Ultrasound, Intravascular2Product Code
- OEDAntimicrobial Blood Pressure Cuff2Product Code
- OEQAngiography/Angioplasty Kit2Product Code
- OERAngioscopic Valvulotome Kit2Product Code
- OESCardiac Catheterization Kit2Product Code
- OEXCardiovascular Catheter Sheath Introducer Kit2Product Code
- OEZCardiovascular Procedure Kit2Product Code
- OFBCatheter Guide Wire Kit2Product Code
- OFCCatheter Introducer Kit2Product Code
- OFDCatheter Introducer Kit2Product Code
- OFECentral Venous Blood Pressure Kit2Product Code
- OMZPulmonary (Pulmonic) Valvuloplasty Catheters/Percutaneous Valvuloplasty Catheter2Product Code
- OFFCentral Venous Catheter Tray2Product Code
- OFHDigital Angiography Tray2Product Code
- ORDOptical Coherence Tomography, Intravascular Catheter2Product Code
- OFJLead Introducer Kit2Product Code
- OFKPercutaneous Atrial Catheter Kit2Product Code
- OFLPercutaneous Sheath Introducer Kit2Product Code
- OFNWinged Intravenous Catheterization Kit2Product Code
- OGZCatheter, Intravascular, Plaque Morphology Evaluation2Product Code
- OWQReprocessed Intravascular Ultrasound Catheter2Product Code
- OZTBalloon Aortic Valvuloplasty2Product Code
- PDUCatheter For Crossing Total Occlusions2Product Code
- PFANon-Invasive Central Venous Manometer2Product Code
- PJACoronary Vascular Physiologic Simulation Software2Product Code
- PNEReprocessed Catheter Introducer2Product Code
- PNOCatheter, Percutaneous, Cutting/Scoring2Product Code
- PPNPercutaneous Catheter, Ultrasound2Product Code
- PQKPercutaneous Catheter For Creation Of An Arteriovenous Fistula For Hemodialysis Access2Product Code
- PTLWire, Guide, Catheter, Exempt2Product Code
- PTMSyringe, Balloon Inflation, Exempt2Product Code
- PUMTemporary Catheter, Embolic Protection, Transcatheter Intracardiac Procedures2Product Code
- QEKAngiographic Coronary Vascular Physiologic Simulation Software2Product Code
- QFJIntravascular Bleed Monitor2Product Code
- QJHReverse Central Venous Recanalization System2Product Code
- QMWCoronary Artery Disease Risk Indicator From Acoustic Heart Signals2Product Code
- QQIInterventional Cardiovascular Implant Simulation Software Device2Product Code
- QYFNeonatal Icu Continuous Non-Invasive Blood Pressure Monitor (Includes Alarms)2Product Code
- QYWHospital Cardiac Telemetry2Product Code
- QYXOutpatient Cardiac Telemetry2Product Code
- NPGCatheter, Infusion, Syringe2Product Code
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart C—Cardiovascular Monitoring DevicesCFR Sub-Part
- Subpart D—Cardiovascular Prosthetic DevicesCFR Sub-Part
- Subpart E—Cardiovascular Surgical DevicesCFR Sub-Part
- Subpart E—Surgical DevicesCFR Sub-Part
- Subpart F—Cardiovascular Therapeutic DevicesCFR Sub-Part
- Subpart F—Therapeutic DevicesCFR Sub-Part
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GORE Tri-Lumen Catheter
- Page Type
- Cleared 510(K)
- PDF* The FDA doesn't provide PDFs for all submissions.
- Analyzed PDF
- 510(k) Number
- K180919
- 510(k) Type
- Traditional
- Applicant
- W. L. Gore and Associates, Inc.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 10/5/2018
- Days to Decision
- 179 days
- Submission Type
- Summary