BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Arrow International LLC (subsidiary of Teleflex Incorporated)

    Reg #: 3013162291 · FEI: 3013162291 · Expires 2026
    View on FDA
    Products
    27
    Proprietary Names
    141
    Establishment Types
    3
    Classifications
    27

    Registration Details

    Registration Name
    Arrow International LLC (subsidiary of Teleflex Incorporated)
    Registration Number
    3013162291
    FEI Number
    3013162291
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    3015 Carrington Mill Blvd.
    City
    Morrisville
    State
    NC
    ZIP
    27560
    Country
    US

    Regulatory Submissions

    510(k) Number
    K200634

    Owner / Operator

    Firm Name
    Arrow International LLC (subsidiary of Teleflex Incorporated
    Operator Number
    2518433
    Address
    3015 Carrington Mill Blvd.
    City
    Morrisville
    State
    NC
    Postal Code
    27560
    Country
    US
    Correspondent
    Divya Raman

    Products

    Device Name Product Code
    System, Balloon, Intra-Aortic And Control DSP
    Needle, Hypodermic, Single Lumen FMI
    Anesthesia Conduction Kit CAZ
    Catheter, Electrode Recording, Or Probe, Electrode Recording DRF
    Wire, Guide, Catheter DQX
    Electrode, Needle GXZ
    Catheter, Flow Directed DYG
    Midline Catheter PND
    Stents, Drains And Dilators For The Biliary Ducts FGE
    Needle, Conduction, Anesthetic (W/Wo Introducer) BSP
    Catheter, Cholangiography GBZ
    Syringe, Piston FMF
    Lubricant, Patient KMJ
    Electrode, Pacemaker, Temporary LDF
    Catheter, Conduction, Anesthetic BSO
    Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days FOZ
    Aspiration Thrombectomy Catheter QEZ
    Catheter, Intravascular, Diagnostic DQO
    Set, Administration, Intravascular FPA
    Epidural Anesthesia Kit OGE
    Stylet, Catheter DRB
    Catheter, Percutaneous DQY
    Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days LJS
    Introducer, Catheter DYB
    Catheter, Ultrasound, Intravascular OBJ
    Cardiovascular Procedure Kit OEZ
    Orthosis, Lumbo-Sacral IPY

    Proprietary Names

    FiberOptix® Intra-Aortic Balloon Catheter Kit EZ-IO Single-Use Procedure Trays StimuCath PNB Catheter Arrow® Continuous Nerve Block Set Arrow® Continuous Nerve Block Kit Arrow Continuous Nerve Block Needle Arrow Continuous Peripheral Nerve Block Kit Arrow Stimulator Adapter Cable Arrow Prep Tray Arrow Nerve Block Prep Tray Arrow StimuCath® Continuous Nerve Block Set Arrow Access Tray Arrow® MultiPolar Electrode Catheter; Arrow® MultiPolar Mapping/Pacing Catheter Arrow Radial Artery Arterial Catheter Arrow StimuQuik® Echo Insulated Peripheral Nerve Block Needle Arrow StimuQuik® Insulated Peripheral Nerve Block Needle Balloon Wedge Pressure Catheter AC3 Series Intra-Aortic Balloon Pump (IABP) Arrow® Nitinol Wire NEW HYDROPHILIC COATING FOR WIRE GUIDES Arrow® Thermodilution Catheters Infusion Port Thermodilution Intra-Aortic Balloon (IAB) Catheter AutoCAT®2 Intra-Aortic Balloon Pump (IABP) Fiber Optic System (FOS) FiberOptix® IAB Catheter, FIBEROPTIX® Intra-Aortic Balloon Catheter, Ultra 8® AutoCAT®2 Series RediGuard® Intra-Aortic Balloon Catheter AutoCAT®2WAVE Intra-Aortic Balloon Pump (IABP) AC3™ Series IABP Arrow® Epidural Needle Arrow Epidural Anesthesia Kit Arrow® Continuous Epidural Needle Arrow Single Shot Epidural Anesthesia Kit Single Shot Epidural Anesthesia Kit FlexTip Plus & Accessories 0.2 Micron Filter 0.2 Micron Flat Epidural Filter S-02200-010N: FILTER COMM: 0.2. MICRON FLAT NRFit, GVS S-02200-010: FILTER COMM: .2 MICRON FLAT, GVS EF-05510N: FILTER COMPONENT NRFit GVS NarrowFlex® Intra-Aortic Balloon (IAB) System NarrowFlex® Intra-Aortic Balloon (IAB) Catheter Arrow Pressure Injectable Midline RediGuard IABs ARROW INTRA-AORTIC BALL LAPAROSCOPIC CHOLANGIOGRAPHY CATHETERIZATION SETS Heparin Coated Thermodilution Ballo Epidural Catheterization Kit with TheraCath(R) and Needle Disposal Feature Arrow TheraCath® Epidural Catheter Arrow Epidural Catheterization Kit with TheraCath® Catheter Arrow StimuQuik Echo Insulated Peripheral Nerve Block Needle Arrow StimuQuik Insulated Peripheral Nerve Block Needle AC3 Series IABP System AC3™ AC3 Optimus™ AutoCAT®2 Intra-Aortic Balloon Pump, AutoCAT2WAVE® Intra-Aortic Balloon System AUTOPILOT® AutoCAT2WAVE® Intra-Aortic Balloon Pump, AutoCAT®2 Intra-Aortic Balloon System Continuous Epidural Anesthesia Kits TROCAR Arrow® MultiPolar Mapping/Pacing Catheter Arrow® MultiPolar Electrode Catheter ARROW® FlexBlock Continuous Peripheral Nerve Block Sets ARROW® FlexBlock Continuous Peripheral Nerve Block Kits ARROW® FlexBlock Continuous Peripheral Nerve Block Catheter RediGuard® Intra-Aortic Balloon System Arrow Central Venous Catheterization Kit Puncture Kit, Disposable Vein Arrow® 10 mL Luer-Slip Loss of Resistance Syringe Arrow® 5 mL Luer-Slip Loss of Resistance Syringe Preox LOR Syringe Rusch Silko Spray Arrow® Temporary Pacing Catheters, Arrow® BiPolar Pacing Catheters Arrow® Wedge Pressure Catheter, Anesthesia Conduct Kit Single Shot Epidural Arrow® Epidural Catheterization Kit with FlexTip Plus® Catheter FlexTip Plus Epidural Catheter FlexTip Plus Epidural Catheterization Kit FlexTip Plus Combined Spinal Epidural Catheterization Kit UltraFlex® Intra-Aortic Balloon (IAB) Catheter, UltraFlex® Intra-Aortic Balloon (IAB) System Ultra 8® Intra-Aortic Balloon (IAB) System Ultra 8® Intra-Aortic Balloon (IAB) Catheter Arrow Pressure Injectable Central Venous Catheterization Kit Ag+ & Ag+BP Pressure Injectable CVC Brachial Plexus Catheter Arrow Single Shot or Continuous (Intermittent) Brachial Plexus Set Pronto LP Extraction Catheter Hands-off Thermodilution Catheters Arrow Epidural Needle Arrow® QuadPolar Electrode Catheter Arrow® QuadPolar Mapping/Pacing Catheter Arrow Epidural Catheterization Kit/Set with FlexTip Plus® Catheter Arrow Epidural Catheterization Kit with FlexTip Plus® Catheter FlexTip Plus® Epidural Catheterization Kit for Caudal Placement SnapLock™ Clamp Fastener Arrow® SnapLock™ Catheter/Syringe Adapter FlexTip Plus® Epidural Catheterization Kit FlexTip Plus® Combined Spinal Epidural Catheterizaiton Kit FlexTip Plus(R) Epidural Catheterization Kit for Lumbar Placement Arrow EZ-IO Intraosseous Vascular Access System EZ-CONNECT STAINLESS STEEL GEN PUR INTERVENTIONAL GUIDE WIRES Arrow® Access Tray Arrow Epidural Catheterization Set with FlexTip Plus® Closed Tip Multi-Port Catheter Arrow Epidural Catheterization Kit with TheraCath® Epidural Catheterization Kit Arrow Epidural Catheterization Kit Arrow Epidural Needle Kit Arrow Stiffening Stylet Arrow SnapLock¿ Clamp Fastener (Bulk Non-Sterile) Arrow Central Venous Catheter Catheterization Kit with Blue FlexTip(R) Catheter M-L CVC w/BlueFlex Tip Arrowg+ard Blue Advance™ PICC pre-loaded with Arrow® TipTracker™ Stylet UltraFlex™ IAB Arrow FlexBlock Continous Peripheral Nerve Block Kits Arrow PSI PERCUTANEOUS SHEATH INTRODUCER StimuCath (19 Ga) Arrow Berman Catheter, Arrow Berman Angiographic Catheter, Wedge Pressure Catheters and Reverse Berman Catheters UltraCath Continuous Nerve Block Kit UltraCath Continuous Nerve Block Catheter Balloon Thermodilution Catheter Balloon Catheter Arrow VPS G4 Internal Jugular Arrow® Wedge Pressure Catheter Kit Arrow® Thermodilution Catheter Kit Arrow® Berman Catheter Kit Arrow VPS AGBA PICC ORTHOSIS, LUMBO-SACRAL AC3 Series IABP System, AutoCAT®2 Intra-Aortic Balloon Pump

    Establishment Types

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