BEUDAMED
    FDA Registration Active 🇺🇸 United States

    AMS100 - MAGELLAN® Autologous Platelet Separator System

    Reg #: 3006788678 · FEI: 3006788678 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    2
    Establishment Types
    3
    Classifications
    2

    Registration Details

    Registration Name
    Arteriocyte Medical Systems, Inc.
    Registration Number
    3006788678
    FEI Number
    3006788678
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    45 South Street
    City
    Hopkinton
    State
    MA
    ZIP
    01748
    Country
    US

    Regulatory Submissions

    510(k) Number
    K021902

    Owner / Operator

    Firm Name
    Arteriocyte Medical Systems, Inc.
    Operator Number
    10023471
    Address
    45 South Street
    City
    Hopkinton
    State
    MA
    Postal Code
    01748
    Country
    US
    Correspondent
    Neil Kizer

    Products

    Device Name Product Code
    Syringe, Piston FMF
    Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use JQC

    Proprietary Names

    AMS100 - MAGELLAN® Autologous Platelet Separator System AMS300 - MAGELLAN® Complete Disposable Kit

    Establishment Types

    Repack or Relabel Medical Device Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device