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

    CATHETERS, H-H ATRIAL AND PERITONEAL

    K Number: K781768 · Decision Nov 14, 1978
    View on FDA
    Classifications
    1
    FEI Numbers
    68
    Registration Numbers
    69
    Same Product Code
    257
    Applicant Total
    42
    Review Days
    29

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    CATHETERS, H-H ATRIAL AND PERITONEAL
    K Number
    K781768
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.5550
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Applicant
    Holter-Hausner Intl.
    Date Received
    October 16, 1978
    Decision Date
    November 14, 1978
    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

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (JXG), ordered by most recent decision date.

    Intellidrop

    FDA 510(k)
    FDA Class 2 ·Neurology

    Sophy Mini Monopressure Valve (SM1)

    FDA 510(k)
    FDA Class 2 ·Neurology

    EVAC-MRI

    FDA 510(k)
    FDA Class 2 ·Neurology

    Codman Libertís Shunt Catheter with Bactiseal and Endexo Technology

    FDA 510(k)
    FDA Class 2 ·Neurology

    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)

    FDA 510(k)
    FDA Class 2 ·Neurology

    External CSF Drainage Ventricular Catheters, External CSF Drainage Lumbar Catheters

    FDA 510(k)
    FDA Class 2 ·Neurology
    View all

    Other Clearances by Holter-Hausner Intl.

    K Number Device Name
    K875287 H-H FLUSHING RESERVOIR
    K874508 H-H EXTERNAL VENTRICULAR DRAINAGE COLLECTION BAG
    K872285 H-H HUNTER ACTIVE TENDON IMPLANT DC
    K872284 H-H HUNTER ACTIVE TENDON IMPLANT PC
    K872293 H-H HUNTER ACTIVE TENDON IMPLANT BC
    K871351 H-H HARRIS NEONATAL NASAL CANNULA SET FOR CPAP
    K870660 H-H EXTERNAL VENTRICULAR DRAIN (EVD) COMP./SYSTEMS
    K865075 H-H SUBGALEAL TROCAR
    K853436 H-H HUNTER PASSIVE TENDON IMPLANT
    K853437 H-H HUNTER TENDON ROD
    Search all 42 clearances from Holter-Hausner Intl. →