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

    Bactiseal Catheters; Bactiseal Barium Striped Catheters; Bactiseal Endoscopic Ventricular Catheter

    K Number: K233445 · Decision Jan 17, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    68
    Registration Numbers
    69
    Same Product Code
    257
    Applicant Total
    8
    Review Days
    90

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    Basic Information

    Device Name
    Bactiseal Catheters; Bactiseal Barium Striped Catheters; Bactiseal Endoscopic Ventricular Catheter
    K Number
    K233445
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.5550
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Integra Lifesciences Production Corporation
    Date Received
    October 19, 2023
    Decision Date
    January 17, 2024
    Product Code
    JXG
    Advisory Committee
    Neurology
    Review Advisory Committee
    NE
    Third Party
    N

    Classifications

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

    Product Code Device Name
    JXG Shunt, Central Nervous System And Components

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    Other Clearances by Integra Lifesciences Production Corporation

    K Number Device Name
    K243531 Codman Libertís Shunt Catheter with Bactiseal and Endexo Technology
    K243552 Codman Libertís™ 1.5 mm EVD Catheter with Bactiseal® and Endexo® Technology with Luer Connection (821761); Codman Libertís™ 1.9 mm EVD Catheter with Bactiseal® and Endexo® Technology with Luer Connection (821762)
    K232890 CereLink ICP Monitor (826820), CereLink ICP Extension Cable (826845)
    K233448 Bactiseal EVD Catheter Sets; Bactiseal Clear EVD Catheter Set
    K223330 Certas Plus Programmable Valves
    K221840 Hakim Programmable Valves, Hakim Precision Fixed Pressure Valves
    K210993 CereLink ICP Monitor