BEUDAMED
    Product Code: DYE FDA class 3 21 CFR 870.3925

    Replacement Heart-Valve

    Cardiovascular

    The Replacement Heart Valve is a cardiovascular implant used to replace a diseased or dysfunctional native heart valve, restoring normal unidirectional blood flow through the heart. It is classified as FDA Class 3, the highest risk category, reflecting the critical nature of the device and the serious consequences of failure; marketing requires Premarket Approval (PMA). The product code is DYE and the applicable regulation is 21 CFR 870.3925, under the Cardiovascular medical specialty. This device is an implant. Note: FDA issued a call for PMA submissions for this device class effective December 9, 1987.

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    510(k)s
    0
    FEI Numbers
    11
    Registration Numbers
    11
    Unique Applicants
    0
    Years Active
    —

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    Basic Information

    Product Code
    DYE
    Device Class
    FDA class 3
    Regulation Number
    870.3925
    Medical Specialty
    Cardiovascular
    Review Panel
    CV
    Submission Type
    2

    Device Characteristics

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

    Definition

    Call for pmas to be filed by 12/9/87 (52 fr 23137 (6/17/87))

    FEI Numbers

    This FDA classification entry is associated with 11 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 11 registration numbers. Click on an entry to view related FDA registrations.