BEUDAMED
    FDA Registration Active 🇺🇸 United States

    SPECTRANETICS CORP.

    Reg #: 3005462046 · FEI: 3005462046 · Expires 2026
    View on FDA
    Products
    2
    Proprietary Names
    2
    Establishment Types
    2
    Classifications
    2

    Registration Details

    Registration Name
    SPECTRANETICS CORP.
    Registration Number
    3005462046
    FEI Number
    3005462046
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    5055 BRANDIN COURT
    City
    FREMONT
    State
    CA
    ZIP
    94538
    Country
    US

    Regulatory Submissions

    510(k) Number
    K150634
    PMA Number
    P050018

    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, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring NWX
    Catheter, Percutaneous, Cutting/Scoring PNO

    Proprietary Names

    Angiosculpt PTCA RX Scoring Balloon Catheter Angiosculpt OTW PTA Scoring Balloon Catheter

    Establishment Types

    Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198