BEUDAMED
    Product Code: PNE FDA class 2 21 CFR 870.1340

    Reprocessed Catheter Introducer

    Cardiovascular

    The Reprocessed Catheter Introducer (product code PNE) is a Class 2 cardiovascular device intended to introduce various cardiovascular catheters into the heart and cardiovascular system, regulated under 870.1340. It requires 510(k) clearance and falls under the cardiovascular medical specialty. The device is not an implant and is not life-sustaining.

    View on FDA
    510(k)s
    7
    FEI Numbers
    4
    Registration Numbers
    4
    Unique Applicants
    4
    Years Active
    10

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    Basic Information

    Product Code
    PNE
    Device Class
    FDA class 2
    Regulation Number
    870.1340
    Medical Specialty
    Cardiovascular
    Review Panel
    CV
    Submission Type
    1

    Device Characteristics

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

    Definition

    Introduce various cardiovascular catheters into the heart and cardiovascular system

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 7 510(k) clearances via K numbers.

    K Number Device Name
    K250305 Reprocessed Agilis NxT Steerable Introducer
    K250314 Medline ReNewal Reprocessed Abbott Agilis Nxt Steerable Introducer
    K232037 Reprocessed VersaCross Steerable Sheath; Reprocessed SureFlex Steerable Guiding Sheath
    K230376 Reprocessed Agilis NxT Steerable Introducer
    K212165 Reprocessed Carto Vizigo Bi-Directional Guiding Sheath
    K170311 Reprocessed Agilis NxT Steerable Introducer
    K152090 Reprocessed Steerable Introducer

    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.