BEUDAMED
    Product Code: NCA FDA class 2 21 CFR 878.4300

    Clip, Implantable, For Coronary Artery Bypass Graft (Cabg)

    General, Plastic Surgery

    The Implantable Clip for Coronary Artery Bypass Graft (CABG) is a small surgical clip implanted in the body to occlude or secure vascular structures during coronary artery bypass graft procedures, facilitating the creation of anastomoses or controlling bleeding. Classified as FDA Class 2, it requires 510(k) premarket clearance under regulation 878.4300 (General and Plastic Surgery specialty). This device carries the implant flag.

    View on FDA
    510(k)s
    3
    FEI Numbers
    0
    Registration Numbers
    0
    Unique Applicants
    3
    Years Active
    1

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    Basic Information

    Product Code
    NCA
    Device Class
    FDA class 2
    Regulation Number
    878.4300
    Medical Specialty
    General, Plastic Surgery
    Review Panel
    SU
    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 3 510(k) clearances via K numbers.

    K Number Device Name
    K013664 COALESCENT SURGICAL U-CLIP
    K011589 CORLINK AAD (3.5 TO 6.0 M M OUTER DIAMETER VESSELS),MODEL 200-064, CORLINK AAD (2.0 TO 4.0 MM OUTER DIAMETER VESSELS), M
    K003446 SYMMETRY AORTIC CLIP SYSTEM