BEUDAMED
    Product Code: DRP FDA class 2 21 CFR 870.5925

    Tourniquet, Automatic Rotating

    Cardiovascular

    The Automatic Rotating Tourniquet is a cardiovascular device used to cyclically and sequentially inflate cuffs on the extremities to redistribute venous blood and reduce preload in patients with acute pulmonary edema or congestive heart failure. It is classified as an FDA Class 2 device, indicating moderate risk, and requires 510(k) premarket notification before marketing. The product code is DRP and it is regulated under 21 CFR 870.5925 within the Cardiovascular medical specialty. This device is eligible for third-party 510(k) review.

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

    Basic Information

    Product Code
    DRP
    Device Class
    FDA class 2
    Regulation Number
    870.5925
    Medical Specialty
    Cardiovascular
    Review Panel
    CV
    Submission Type
    1

    Device Characteristics

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

    FEI Numbers

    This FDA classification entry is associated with 3 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 3 registration numbers. Click on an entry to view related FDA registrations.