BEUDAMED
    Product Code: NMM FDA class 2 21 CFR 870.1250

    Catheter, Angioplasty, Peripheral, Transluminal, Reprocessed

    Cardiovascular

    The peripheral transluminal angioplasty catheter (reprocessed) is a cardiovascular device used to dilate narrowed or blocked peripheral blood vessels by inflating a balloon at the catheter tip. It is classified as FDA Class 2 under regulation 870.1250 in the Cardiovascular specialty, requiring 510(k) clearance. As a reprocessed device, reprocessing validation data must be included in any 510(k) submission per applicable FDA guidance. Product code NMM is not eligible for third-party 510(k) review.

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    510(k)s
    0
    FEI Numbers
    0
    Registration Numbers
    0
    Unique Applicants
    0
    Years Active
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    Basic Information

    Product Code
    NMM
    Device Class
    FDA class 2
    Regulation Number
    870.1250
    Medical Specialty
    Cardiovascular
    Review Panel
    CV
    Submission Type
    1

    Device Characteristics

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

    Definition

    Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf)