BEUDAMED
    Product Code: NKQ FDA class 2 21 CFR 870.1330

    Guidewire, Catheter, Reprocessed

    Cardiovascular

    The Reprocessed Catheter Guidewire is a reprocessed cardiovascular guidewire used to navigate catheters through vascular structures during interventional procedures; reprocessing validation data must be included in a 510(k) submission as required by FDA regulations. It is classified as FDA Class 2 (Special Controls), requiring 510(k) clearance, under product code NKQ and regulation 21 CFR 870.1330 in the Cardiovascular specialty. The device is not an implant and is not life-sustaining.

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    510(k)s
    0
    FEI Numbers
    4
    Registration Numbers
    4
    Unique Applicants
    0
    Years Active
    —

    Basic Information

    Product Code
    NKQ
    Device Class
    FDA class 2
    Regulation Number
    870.1330
    Medical Specialty
    Cardiovascular
    Review Panel
    CV
    Submission Type
    1

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
    —
    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).

    FEI Numbers

    This FDA classification entry is associated with 4 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 4 registration numbers. Click on an entry to view related FDA registrations.