BEUDAMED
    Product Code: DST FDA class 2 21 CFR 870.3260

    Clip, Vena-Cava

    Cardiovascular

    The Vena-Cava Clip is an implantable cardiovascular device used to partially or completely occlude the inferior vena cava, typically to prevent pulmonary embolism by restricting the passage of blood clots from the lower extremities to the lungs. It is classified as an FDA Class 2 device, indicating moderate risk, and requires 510(k) premarket notification before marketing. The product code is DST and it is regulated under 21 CFR 870.3260 within the Cardiovascular medical specialty. This device is flagged as an implant.

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    510(k)s
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Unique Applicants
    1
    Years Active
    —

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    Basic Information

    Product Code
    DST
    Device Class
    FDA class 2
    Regulation Number
    870.3260
    Medical Specialty
    Cardiovascular
    Review Panel
    CV
    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 1 510(k) clearance via K numbers.

    K Number Device Name
    K900207 EPICARDIA 4000

    FEI Numbers

    This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.