BEUDAMED
    Product Code: MZY FDA class 2 21 CFR 870.3450

    Graft, Vascular, Stainless Steel Tunneler

    Cardiovascular

    The Stainless Steel Tunneler for Vascular Graft is a surgical instrument used during vascular bypass procedures to create a subcutaneous or anatomic tunnel through which a vascular graft is passed to its intended anastomosis site, such as in coronary artery bypass grafting or peripheral vascular surgery. Classified as FDA Class 2, it requires 510(k) premarket clearance under regulation 870.3450 (Cardiovascular specialty).

    View on FDA
    510(k)s
    0
    FEI Numbers
    17
    Registration Numbers
    17
    Unique Applicants
    0
    Years Active
    —

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    Basic Information

    Product Code
    MZY
    Device Class
    FDA class 2
    Regulation Number
    870.3450
    Medical Specialty
    Cardiovascular
    Review Panel
    CV
    Submission Type
    4

    Device Characteristics

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

    FEI Numbers

    This FDA classification entry is associated with 17 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 17 registration numbers. Click on an entry to view related FDA registrations.