BEUDAMED
    FDA Registration Active 🇺🇸 United States

    TightRail Sub-C Rotating Dilator Sheath

    Reg #: 3007284006 · FEI: 3007284006 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    SPECTRANETICS CORP.
    Registration Number
    3007284006
    FEI Number
    3007284006
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    9965 Federal Drive
    City
    Colorado Springs
    State
    CO
    ZIP
    80921
    Country
    US

    Regulatory Submissions

    510(k) Number
    K161333

    Owner / Operator

    Firm Name
    Philips Medical Systems International BV
    Operator Number
    2939520
    Address
    Veenpluis 6
    City
    Best
    State
    NL-NOTA
    Postal Code
    5684PC
    Country
    NL

    Products

    Device Name Product Code
    Dilator, Vessel, For Percutaneous Catheterization DRE

    Proprietary Names

    TightRail Sub-C Rotating Dilator Sheath

    Establishment Types

    Manufacture Medical Device