BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    Medline ReNewal Reprocessed ViewFlex Xtra ICE Catheter

    K Number: K232130 · Decision Dec 15, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    19
    Registration Numbers
    19
    Same Product Code
    29
    Applicant Total
    4
    Review Days
    151

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    Basic Information

    Device Name
    Medline ReNewal Reprocessed ViewFlex Xtra ICE Catheter
    K Number
    K232130
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1200
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Surgical Instrument Services and Savings, Inc.
    Date Received
    July 17, 2023
    Decision Date
    December 15, 2023
    Product Code
    OWQ
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    OWQ Reprocessed Intravascular Ultrasound Catheter

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    Other Clearances by Surgical Instrument Services and Savings, Inc.

    K Number Device Name
    K162751 Medline ReNewal Reprocessed Ligasure Curved, Small Jaw Open Sealer/Divider
    K152313 Medline ReNewal Reprocessed Endopath Endoscopic Instruments
    K150524 Medline ReNewal Reprocessed Harmonic FOCUS+ Shears without Adaptive Tissue Technology