BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Cordis US Corp.

    Reg #: 1016427 · FEI: 1016427 · Expires 2026
    View on FDA
    Products
    22
    Proprietary Names
    114
    Establishment Types
    3
    Classifications
    22

    Registration Details

    Registration Name
    Cordis US Corp.
    Registration Number
    1016427
    FEI Number
    1016427
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    14201 N.W. 60TH AVE.
    City
    Miami Lakes
    State
    FL
    ZIP
    33014
    Country
    US

    Regulatory Submissions

    510(k) Number
    K862006
    PMA Number
    P120002

    Owner / Operator

    Firm Name
    Cordis US Corp.
    Operator Number
    1016427
    Address
    5452 Betsy Ross Drive, --
    City
    Santa Clara
    State
    CA
    Postal Code
    95054
    Country
    US
    Correspondent
    Linda Ruedy

    Products

    Device Name Product Code
    Catheter, Intravascular, Diagnostic DQO
    Catheter, Angioplasty, Peripheral, Transluminal LIT
    Wire, Guide, Catheter DQX
    Temporary Carotid Catheter For Embolic Capture NTE
    Dilator, Vessel, For Percutaneous Catheterization DRE
    Stents, Drains And Dilators For The Biliary Ducts FGE
    Catheter, Percutaneous DQY
    Introducer, Catheter DYB
    Catheter For Crossing Total Occlusions PDU
    Filter, Intravascular, Cardiovascular DTK
    Cardiovascular Procedure Kit OEZ
    Stent, Superficial Femoral Artery NIP
    Device, Biopsy, Endomyocardial DWZ
    Device, Hemostasis, Vascular MGB
    Set, Administration, Intravascular FPA
    Cardiac Catheterization Kit OES
    Pulmonary Stent QWC
    Dilator, Esophageal KNQ
    Stent, Iliac NIO
    Stent, Renal NIN
    Clamp, Vascular DXC
    Stent, Carotid NIM

    Proprietary Names

    7F & 8F High Flow Diagnostic Catheter SABERX RADIANZ Percutaneous Transluminal Angioplasty Dilatation Catheter Vassallo GT Crossing14 ATW Marker Wire Steerable Guidewire ANGIOGUARD XP and ANGIOGUARD RX Emboli Capture Guidewire AVANTI+ Catheter Sheath Introducer S.M.A.R.T. Flex Biliary Self-Expanding Stent System VASSALLO GT 018 Floppy Peripheral Guide Wire Emerald Guidewire Palmaz Genesis Transhepatic Biliary Stent ADROIT Guiding Catheter Cordis BRITECROSS Support Catheter SABER® 18 Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter VASSALLO GT EXT Vista Brite Tip Catheters Smart Stent RAILWAY™ Sheathless Access System INFINITI AMBI Diagnostic Catheter PALMAZ GENESIS Peripheral Stent on OPTA PRO 35" Delivery System OUTBACK® Elite Re-Entry Catheter OPTEASE Vena Cava Filter and OPTEASE Retrieval Catheter VASSALLO GT Hybrid Guide Wire 6F Super Torque Plus Diagnostic Catheter 4F Super Torque Diagnostic Catheter 5.2F Super Torque Plus Diagnostic Catheter 6F Super Torque Diagnostic Catheter Palmaz Genesis Transhepatic Biliary Stent on Slalom Delivery System 9F Envoy Guiding Catheter SABER 14 PTA Dilatation Catheter SABERX 14 PTA Dilatation Catheter SABER™ 35 Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter Modification to Smart Control CORPAC - Cardiovascular Procedure Kit PROPAC Diagnostic Procedural System PRIMOPAC - Cardiovascular Procedure Kit S.M.A.R.T. RADIANZ Vascular Stent System S.M.A.R.T. CONTROL and S.M.A.R.T. Vascular Stent System VASSALLO GT 018 G12; VASSALLO GT 018 G30 Slalom Thrill PTA Catheter Vista Brite Tip Guiding Catheters Introducer Guide Vessel Dilator VASSALLO GT 018 Hybrid Trapease Permanent Vena Cava Filter Palmaz Genesis Transhepatic Biliary Stent on Slalom18 Delivery System Biopsy Forceps Brite Tip Sheath Introducer Brite Tip Catheter Sheath Introduce Cordis EXOSEAL Vascular Closure Device Angiographic Catheter Extension ANGIOGRAPHIC CATHETERIZATION SET Storq Steerable Guidewire Marker Wire Steerable Guidewire (Stabilizer & WIZDOM with Radiopaque Markers) S.M.A.R.T. Flex Vascular Stent System RAIN Sheath Transradial S.M.A.R.T.® ControlTM Nitinol Stent System Palmaz XL Transhepatic Biliary Stent System Avanti Trans-radial sheath introducer kit Palmaz Blue 18 Transhepatic biliary System PALMAZ® Angiographic Catheters 4F Tempo Aqua Diagnostic Catheter Envoy and Vista Brite Tip ( modification) Powerflex Extreme Powerflex P3 Percutaneous Transluminal Angioplasty (PTA) Catheter OPTA Pro Percutaneous Transluminal Angioplasty (PTA) Catheter Palmaz Genesis Transhepatic Biliary Stent and Delivery System Powerflex Pro Percutaneous Transluminal Angioplasty Catheter Optease Vena Cava Filter PALMAZ MULLINS XD Pulmonary Stent Maxi LD Large Diameter Balloon Dilatation Catheter Biopsy Foceps 5F & 6F Infiniti Diagnostic Catheter Envoy & Vista Brite Tip AQUATRACK® Hydrophilic Nitinol Guidewire Mynx Control Vascular Closure Device MynxGrip Vascular Closure Device MYNX CONTROL™ Venous Vascular Closure Device 6F-12F SV Steerable Guidewire Palmaz Genesis Transhepatic Biliary Stent (modification) Maxi LD Wizdom Extra Support with Markers Wizdom Extra Support Guidewire Stabilizer Support Guidewire Steerable Guidewire Shinobi Plus Steerable Guidewire ATW All Track Wire Steerable Guidewire Wizdom Steerable Guidewire with Markers Stabilizer Plus Steerable Guidewire Shinobi Steerable Guidewire Stabilizer Balance Performance Steerable Guidewire Wizdom Steerable Guidewire RAIN Sheath™ Tibial Pedal Introducer Brite Tip Catheter Flex Iliac Stent System Dilatation Catheters AVIATOR PLUS PTA Balloon Dilatation Catheter STABILIZER XS Guidewire STABILIZER Extra Support Guidewire Maxi LD PTA Balloon Catheter Palmaz Balloon Expandable Stent VASSALLO GT Guide Wire Zephyr Vascular Compression Band PRECISE NITINOL STENT SYSTEM 4F Infiniti Diagnostic Catheter 4F & 5F Tempo Diagnostic Catheters 4F & 5F Nylex Diagnostic Catheters S.M.A.R.T. CONTROL Nitinol Stent Transhepatic Biliary System (modification) 5F SuperTorque Diagnostic Catheter 5F ADROIT Guiding Catheter S.M.A.R.T. and S.M.A.R.T. CONTROL Nitinol Stent System ELITECROSS™ Support Catheter Frontrunner 5F Super Torque MB Diagnostic Catheter

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility Manufacture Device in the United States for Export Only