BEUDAMED
    Product Code: PYX FDA class 3 21 CFR 870.4360

    Temporary Non-Roller Type Right Heart Support Blood Pump

    Cardiovascular

    The Temporary Non-Roller Type Right Heart Support Blood Pump is a device intended to provide temporary partial or full right heart circulatory support in patients with acute right heart failure. It is classified as a Class 3 device under regulation 870.4360, the highest risk category requiring Premarket Approval (PMA) due to its critical cardiovascular support function. The product code is PYX, and it falls within the Cardiovascular (CV) medical specialty. It is flagged as life-sustaining, reflecting the critical nature of its circulatory support role.

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    510(k)s
    0
    FEI Numbers
    2
    Registration Numbers
    2
    Unique Applicants
    0
    Years Active
    —

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    Basic Information

    Product Code
    PYX
    Device Class
    FDA class 3
    Regulation Number
    870.4360
    Medical Specialty
    Cardiovascular
    Review Panel
    CV
    Submission Type
    2

    Device Characteristics

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

    Definition

    Providing temporary partial or full right heart circulatory support.

    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.