BEUDAMED
    FDA Registration Active 🇺🇸 United States

    BARD PERIPHERAL VASCULAR, INC.

    Reg #: 2020394 · FEI: 2020394 · Expires 2026
    View on FDA
    Products
    49
    Proprietary Names
    210
    Establishment Types
    3
    Classifications
    49

    Registration Details

    Registration Name
    BARD PERIPHERAL VASCULAR, INC.
    Registration Number
    2020394
    FEI Number
    2020394
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    1625 W 3rd St
    City
    TEMPE
    State
    AZ
    ZIP
    85281
    Country
    US

    Regulatory Submissions

    510(k) Number
    K990705
    PMA Number
    P060002

    Owner / Operator

    Firm Name
    C. R. Bard, Inc.
    Operator Number
    2212754
    Address
    1 Becton Drive
    City
    Franklin Lakes
    State
    NJ
    Postal Code
    07417
    Country
    US

    Products

    Device Name Product Code
    Introducer, Catheter DYB
    Catheter For Crossing Total Occlusions PDU
    Source, Brachytherapy, Radionuclide KXK
    Electrosurgical, Cutting & Coagulation & Accessories GEI
    Catheter, Hemodialysis, Implanted MSD
    Instrument, Biopsy KNW
    System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment PFV
    Tray, Surgical, Needle FSH
    Biopsy Needle FCG
    Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene DXZ
    Sterilization Wrap Containers, Trays, Cassettes & Other Accessories KCT
    Catheter, Angioplasty, Peripheral, Transluminal LIT
    Catheter, Percutaneous DQY
    Balloon Aortic Valvuloplasty OZT
    Pulmonary (Pulmonic) Valvuloplasty Catheters/Percutaneous Valvuloplasty Catheter OMZ
    Prosthesis, Vascular Graft, Of 6mm And Greater Diameter DSY
    Filter, Intravascular, Cardiovascular DTK
    Wire, Guide, Catheter DQX
    Catheter, Peripheral, Atherectomy MCW
    Staple, Implantable GDW
    Clip, Implantable FZP
    Stent, Iliac NIO
    Injector And Syringe, Angiographic DXT
    Bag, Polymeric Mesh, Pacemaker DSW
    Guide, Needle, Surgical GDF
    Marker, Radiographic, Implantable NEU
    Syringe, Balloon Inflation MAV
    Iliac Covered Stent, Arterial PRL
    Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass DWF
    Catheter, Percutaneous, Cutting/Scoring PNO
    Transducer, Ultrasonic, Diagnostic ITX
    Stents, Drains And Dilators For The Biliary Ducts FGE
    Needle, Hypodermic, Single Lumen FMI
    Peripheral Mechanical Thrombectomy With Aspiration QEW
    Prosthesis, Vascular Graft, Of Less Then 6mm Diameter DYF
    Instruments, Surgical, Cardiovascular DWS
    System, Applicator, Radionuclide, Manual IWJ
    Bottle, Collection, Vacuum KDQ
    Device, Vascular, For Promoting Embolization KRD
    Stent, Iliac Vein QAN
    Peritoneal, Drainage Catheter For Refractory Ascites, Long-Term Indwelling PNG
    Apparatus, Suction, Patient Care DWM
    Probe, Uptake, Nuclear IZD
    Needle, Aspiration And Injection, Disposable GAA
    Percutaneous Catheter For Creation Of An Arteriovenous Fistula For Hemodialysis Access PQK
    Dilator, Vessel, Surgical DWP
    Device, Percutaneous Retrieval MMX
    Stent, Superficial Femoral Artery NIP
    Graft, Vascular, Stainless Steel Tunneler MZY

    Proprietary Names

    Crosser iQ CTO Recanalization System 125 Implant Seeds BrachySource Seed Implants ESU-1 Electrosurgical Generator GlidePath 7.5F Long-Term Hemodialysis Catheter EnCor Breast Biopsy Probe with Rinse Tube – 10G EnCor Breast Biopsy Probe with Rinse Tube – 7G EnCor Breast Biopsy Probe with Rinse Tube – 7G Vertical EnCor Breast Biopsy Probe with Rinse Tube – 12G EnCor Breast Biopsy Probe with Rinse Tube – 10G Vertical EnCor Breast Biopsy Probe with Rinse Tube – 12G Vertical Flair Endovascular Stent Graft Soft Tissue Biopsy Drug Free Tray Jamshidi Menghini Soft Tissue Biopsy Needle/Syringe Economy Illinois Sternal/lliac Bone Marrow Aspiration Tray Safety Soft Tissue Biopsy Tray Economy Soft Tissue Biopsy Tray Illinois Bone Marrow Aspiration/Intraosseous Infusion Needle Soft Tissue Biopsy Tray Jamshidi Bone Marrow Biopsy/Aspiration Needle Jamshidi Menghini Soft Tissue Biopsy Tray Bard Sauvage Filamentous Fabric Peripheral Vascular (PV) Sheath Tunneler Sterilization Cassette Arteriovenous (AV) Sheath Tunneler Sterilization Cassette Ultraverse 014 and 018 PTA Balloon Dilatation Catheters Vida BAV Balloon Valvuloplasty Catheter Vida PTV Dilatation Catheter Conquest 40 PTA Dilatation Catheter Atlas Gold PTA Dilatation Catheter Distaflo Bypass Graft Simon Nitinol Vena Cava Filter Rotarex Atherectomy System Dorado PTA Balloon Catheter UltraClip II Tissue Marker E-Luminexx Vascular Stent System LifeStar Vascular Stent System Jamshidi Bone Marrow Biopsy and Aspiration Tray T-Handle Jamshidi Bone Marrow Biopsy/Aspiration Needle Instrument, biopsy Jamshidi Evolve Bone Marrow Biopsy and Aspiration Trays Safe-T PLUS Trays Jamshidi Evolve Bone Marrow Biopsy/Aspiration Needle T-Handle Jamshidi Bone Marrow Biopsy and Aspiration Trays Venclose EVSRF Catheter Venclose digiRF Generator EnCor Breast Biopsy System - EnCor Probes, Drivers, and Accessories EnCor Breast Biopsy System FlowMate Injector Bard Parsonnet Pulse Generator Pouch (Small, Large, X-Large) DuaLok Breast Lesion Localization Wire Ghiatas Beaded Breast Localization Wire Bard Magnum Reusable Core Biopsy Instrument Gel Mark UltraCor Biopsy Site Markers TruGuide Coaxial Biopsy Needles Bard TruGuide Disposable Coaxial Biopsy Needles Seeker Crossing Support Catheter Presto Inflation Device BD Trek™ Bone Marrow Biopsy System BD Trek™ Power Driver BD Trek™ Bone Lesion Biopsy System BD Trek™ Sterile Sleeve LifeStream Balloon Expandable Vascular Covered Stent Vaccess PTA Dilatation Catheter Bard Burbank Carotid Bypass Shunt Bard Carotid Bypass Shunt Bard Javid Carotid Bypass Shunt Bard Brener Carotid Bypass Shunt ePTFE Cardiovascular Patch Spacer Links SourceLink Connectors SourceLink Brachytherapy Seeding EnCor Encompass VisiLoc MRI Introducer Set EnCor Probe Introducer EnCor VisiLoc MRI Introducer Set Covera Vascular Covered Stent Vascutrak PTA Dilatation Catheter HemoStar™ Long Term Hemodialysis Catheter GlidePath™ Long Term Hemodialysis Catheter HemoStar XK™ Long Term Hemodialysis Catheter UltraClip II US Tissue Marker Marker (Ribbon) UltraClip Dual Trigger Tissue GlidePath™ 13F Long Term Hemodialysis Catheter GlidePath™ 10F Long Term Dialysis Catheter SenoMark UltraCor MRI Biopsy Site Markers SenoMark Biopsy Site Markers PT Stepper Surepoint PT Stepper Dynaflo Bypass Grafts UltraCor Twirl Breast Tissue Marker Magnum Core Biopsy Needles LifeStent XL Biliary Stent System LifeStent Biliary Stent System Illinois Bone Marrow Aspiration Needle Illinois Bone Marrow Aspiration Tray T-Handle Illinois Bone Marrow Aspiration Tray Safe-T PLUS Tray T-Handle Illinois Bone Marrow Aspiration Needle Bard Mission Disposable Core Biopsy Instrument Bard Mission Disposable Core Biopsy Instrument Kit EnCor Probe Lifestent XL Biliary Stent System Rotarex S Straub Endovascular System UltraClip II MR Tissue Marker True Dilatation Balloon Valvuloplasty Catheter IMPRA Carboflo ePTFE Vascular Grafts Kelly-Wick AV Access Tunneler Conquest PTA Dilatation Catheter BrachyStar Brachytherapy Needles brachytherapy seed implant needles BrachyStar Needles QuickLink Loader QuickLink Relay System SourceLink Loader Usher Support Catheter Sidekick Support Catheter ReadyLink Delivery System QuickLink Delivery System Gel Mark Ultra Biopsy Site Markers UltraCor Biopsy Site Markers Recon Support Catheter Aspirex Thrombectomy System UltraScore Focused Force PTA Balloon Pristine™ Long Term Hemodialysis Catheter Prosthesis Vascular Graft of less than 6mm Valeo Biliary Stent Caterpillar Arterial Embolization Device Caterpillar Micro Arterial Embolization Device Seedlinks SourceLink Spacers Liverty™ TIPS Access Set Ultraverse 035 PTA Balloon Dilatation Catheter BD EleVation Breast Biopsy System Venovo Venous Stent System EnCor EnCompass Breast Biopsy and Tissue Removal System Vacora Vacuum Assisted Biopsy Sys UltraClip Dual Trigger Breast Tissue Marker (Wing and Coil) Atlas PTA Balloon Dilatation Catheter EnCor Ultra Breast Biopsy System and Accessories EnCor Enspire Breast Biopsy System and Accessories Denali Vena Cava Filter, Jugular/Subclavian Delivery Kit Denali Vena Cava Filter, Femoral Delivery Kit PeritX™ 2L Drainage Starter Pack PeritX™ 2L Drainage Kit PeritX™ 2L Drainage Starter Tote PeritX™ Peritoneal Catheter System Crosser Generator Crosser CTO Recanalization Catheters 14S, S6 LifeStar Biliary Stent System E-LUMINEXX Biliary Stent System Venclose Foot Pedal Venclose RF Ablation Catheters Venclose EVSRF System Venclose EVSRF Catheters UltraClip II Tissue Marker Wing and UltraClip II Tissue Marker Coil Stabilization System SurePoint Tracker Stepping and True BAV BAlloon Valvuloplasty Catheter EnCor Ultrasound Stylet and Coaxial Marquee™ Disposable Core Biopsy Instrument Marquee™ Disposable Core Biopsy Instrument Kit GlidePath Retro Long Term Hemodialysis Catheter Gamma Finder, Sterile Sleeve Handheld Gamma Finder True Flow Valvulplasty Perfusion Catheter Crosser CTO Recanalization Catheter EnCor Breast Biopsy System – Accessories Chiba Fine Needle Aspiration Device WavelinQ EndoAVF System Bard Max-Core Disposable Core Biopsy Instrument Bard Monopty Disposable Core Biopsy Instrument Kit Bard Monopty Disposable Core Biopsy Instrument Bard Marquee Disposable Core Biopsy Instrument Kit Bard Marquee Disposable Core Biopsy Instrument Parsonnet Vascular Probe Starchmark UltraCor Breast Tissue Marker Starchmark Breast Tissue Marker Highlander 014 PTA Balloon Dilatation Catheter Recovery Cone Removal System SurePoint Stepping and Stabilization System Brachysource Seed Implants with Sourcecap Bioabsorbable Caps Venclose Maven System Venclose Maven Catheter LifeStent 5F Vascular Stent System Lifestent Solo Vascular Stent System Lifestent and Lifestent XL Vascular Stent System Denali™ Vena Cava Filter System – Femoral and Jugular/Subclavian Delivery Kit Fluency Plus Endovascular Stent Graft Venaflo II Bypass Graft PTFE Felt Bard PTFE Felt Pledget Low Porosity PTFE Felt PTFE Felt (Thick) Bard PTFE Braided Tape Bard PTFE Thick Felt Pledget SenoMark UltraCor Breast Tissue Marker SenoMark Ultra Breast Tissue Marker Tunneler Arteriovenous (AV) Sheath Tunneler Ultraverse RX PTA Balloon Dilatation Catheter Finesse Ultra Breast Biopsy System Driver WavelinQ Generator Palladium-103 Seed Implant Kits Franseen FNA Needle

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device