BEUDAMED
    Product Code: ORD FDA class 2 21 CFR 870.1200

    Optical Coherence Tomography, Intravascular Catheter

    Cardiovascular

    The Optical Coherence Tomography, Intravascular Catheter (product code ORD) is a catheter-based imaging device used for intravascular visualization of the coronary vessel lumen and wall in patients who are candidates for transluminal interventional procedures. It uses optical coherence tomography technology to generate high-resolution cross-sectional images of coronary arteries during cardiac catheterization. As an FDA Class 2 device under regulation 870.1200, it requires 510(k) premarket clearance and falls within the Cardiovascular specialty. The device is not an implant and is not life-sustaining.

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    510(k)s
    0
    FEI Numbers
    9
    Registration Numbers
    9
    Unique Applicants
    0
    Years Active
    —

    Basic Information

    Product Code
    ORD
    Device Class
    FDA class 2
    Regulation Number
    870.1200
    Medical Specialty
    Cardiovascular
    Review Panel
    CV
    Submission Type
    1

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    Definition

    For intravascular visualization of the coronary vessel lumen and wall in patients who are candidates for transluminal interventional procedures.

    FEI Numbers

    This FDA classification entry is associated with 9 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 9 registration numbers. Click on an entry to view related FDA registrations.