BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Philips Image Guided Therapy Corporation

    Reg #: 3016257349 · FEI: 3016257349 · Expires 2026
    View on FDA
    Products
    4
    Proprietary Names
    11
    Establishment Types
    3
    Classifications
    4

    Registration Details

    Registration Name
    Philips Image Guided Therapy Corporation
    Registration Number
    3016257349
    FEI Number
    3016257349
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    5905 Nathan Lane North
    City
    Plymouth
    State
    MN
    ZIP
    55442
    Country
    US

    Regulatory Submissions

    510(k) Number
    K182972
    PMA Number
    P230021

    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
    Catheter, Peripheral, Atherectomy MCW
    Stent, Iliac Vein QAN
    Drug-Eluting Peripheral Transluminal Angioplasty Catheter ONU
    Catheter, Intravascular Occluding, Temporary MJN

    Proprietary Names

    Phoenix Handle with Wire Support Clip Phoenix Pre-Deflected Atherectomy System 2.2mm x 130cm Phoenix Pre-Deflected Atherectomy Catheter 2.2mm x 130cm Duo Venous Stent System Stellarex 035” OTW Drug-coated Angioplasty Balloon Stellarex Drug-Coated Angioplasty Balloon Bridge Plus Occlusion Balloon Catheter Phoenix Pre-Deflected Atherectomy System 2.4mm x 130cm Phoenix Atherectomy System 1.5mm x 149cm Phoenix Pre-Deflected Atherectomy Catheter 2.4mm x 130cm Phoenix Atherectomy Catheter 1.5mm x 149cm

    Establishment Types

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