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    FDA Registration Active 🇨🇷 Costa Rica

    Nitinol Devices & Components Costa Rica, S. R. L.

    Reg #: 3009018440 · FEI: 3009018440 · Expires 2026
    View on FDA
    Products
    17
    Proprietary Names
    32
    Establishment Types
    1
    Classifications
    17

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    Registration Details

    Registration Name
    Nitinol Devices & Components Costa Rica, S. R. L.
    Registration Number
    3009018440
    FEI Number
    3009018440
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Coyol Free Zone, Building B14, B15, B25, B28
    City
    El Coyol Alajuela
    Country
    CR

    Owner / Operator

    Firm Name
    Confluent Medical Technologies, Inc.
    Operator Number
    10033958
    Address
    6263 N. Scottsdale Road, Suite 224
    City
    Scottsdale
    State
    AZ
    Postal Code
    85250
    Country
    US
    Correspondent
    Rich Brown

    Products

    Device Name Product Code
    Valvulotome MGZ
    Dilator, Esophageal KNQ
    Catheter, Angioplasty, Peripheral, Transluminal LIT
    Catheter, Percutaneous DQY
    Stent Graft, Infrapopliteal, Venous Arterialization QWN
    Device, Percutaneous Retrieval MMX
    Catheters, Transluminal Coronary Angioplasty, Percutaneous LOX
    Percutaneous Catheter, Ultrasound PPN
    Arthroscope HRX
    Cement, Bone, Vertebroplasty NDN
    Stents, Drains And Dilators For The Biliary Ducts FGE
    Catheter For Crossing Total Occlusions PDU
    Wire, Guide, Catheter DQX
    Eustachian Tube Balloon Dilation Device PNZ
    Suture, Nonabsorbable, Synthetic, Polyethylene GAT
    Ear, Nose, And Throat Stereotaxic Instrument PGW
    Instrument, Ent Manual Surgical LRC

    Proprietary Names

    LimFlow Vector MAXI LD Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter POWERFLEX PRO Percutaneous Transluminal Angioplasty Catheter SLALOM Percutaneous Transluminal Angioplasty (PTA) Catheter LimFlow Extension Stent Graft LimFlow Crossing Stent Graft LimFlow V-Ceiver FLASH Ostial System Shockwave M5 Intravascular Lithotripsy (IVL) Catheter Synthes Synflate Vertebral Balloon System POWERFLEX P3 Percutaneous Transluminal Angioplasty (PTA) Catheter Flash Ostial System OTW PALMAZ GENESIS Transhepatic Biliary Stent on OPTA PRO 35 Delivery System Cordis SABER 35 Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter LimFlow ARC SABERX RADIANZ Percutaneous Transluminal Angioplasty Dilatation Catheter MAXI LD LARGE DIAMETER BALLOON DILATATION CATHETER Aquatrack Hydrophilic Nitinol Guidewire AVIATOR PLUS Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter FLASH MINI Ostial System Shockwave M5+ Peripheral Intravascular Lithotripsy (IVL) Catheter SABER Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter Cordis SABER 35 PTA Dilatation Catheter Medtronic NuVent Eustachian Tube Dilation Balloon MaxBraid BroadBand Suture And Expressbraid BroadBand Graft Manipulation Suture TruDi NAVWIRE Sinus Navigation Guidewire PALMAZ GENESIS Transhepatic Biliary Stent on SLALOM 18" Delivery System PALMAZ GENESIS Peripheral Stent on Slalom 18" Delivery System Next Generation Balloon Dilation System PALMAZ BLUE 18 Transhepatic Biliary Stent System FLASH-C PTCA BALLOON DILATATION CATHETER - 4MM X 14MM X 135CM, FLASH-C PTCA BALLOON DILATATION CATHETER - 4MM X 19MM X 1 FLASH PTA BALLOON DILATATION CATHETER - 4MM X 14MM X 135CM, FLASH PTA BALLOON DILATATION CATHETER - 4MM X 19MM X 135CM

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)