BEUDAMED
    Product Code: HCE FDA class 2 21 CFR 882.5175

    Clamp, Carotid Artery

    Neurology

    The Carotid Artery Clamp is an implanted neurovascular device used to progressively or permanently occlude the carotid artery as a treatment for certain intracranial aneurysms that are not amenable to direct surgical clipping, reducing blood flow to the aneurysm to promote thrombosis. It is classified as a Class 2 device (moderate risk), requiring 510(k) premarket notification, and is designated as an implant. The product code is HCE under regulation 21 CFR 882.5175 in the Neurology specialty. The implant flag is active for this device.

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    510(k)s
    2
    FEI Numbers
    2
    Registration Numbers
    2
    Unique Applicants
    2
    Years Active
    5

    Basic Information

    Product Code
    HCE
    Device Class
    FDA class 2
    Regulation Number
    882.5175
    Medical Specialty
    Neurology
    Review Panel
    NE
    Submission Type
    1

    Device Characteristics

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

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 2 510(k) clearances via K numbers.

    K Number Device Name
    K870399 SELVERSTONE CLAMP SALIBI CLAMP
    K811821 CAROTID ARTERY CLAMP & TOOLS

    FEI Numbers

    This FDA classification entry is associated with 2 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.