BEUDAMED
    Product Code: NKS FDA class 2 21 CFR 870.1280

    Catheter, Steerable, Reprocessed

    Cardiovascular

    The Reprocessed Steerable Catheter is a reprocessed cardiovascular catheter with a deflectable tip used for navigation within the heart or vascular system during electrophysiology or other interventional procedures; reprocessing validation data must be included in a 510(k) submission. It is classified as FDA Class 2 (Special Controls), requiring 510(k) clearance, under product code NKS and regulation 21 CFR 870.1280 in the Cardiovascular specialty. The device is eligible for third-party review and is not an implant or life-sustaining device.

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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
    NKS
    Device Class
    FDA class 2
    Regulation Number
    870.1280
    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).