BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇦 Canada

    TITANIUM CATHETER EXTENDER

    K Number: K910785 · Decision Aug 22, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    26
    Registration Numbers
    26
    Same Product Code
    47
    Applicant Total
    9
    Review Days
    178

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    Basic Information

    Device Name
    TITANIUM CATHETER EXTENDER
    K Number
    K910785
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5630
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Accurate Surgical Instruments Co.
    Date Received
    February 25, 1991
    Decision Date
    August 22, 1991
    Product Code
    FJS
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    FJS Catheter, Peritoneal, Long-Term Indwelling

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    Other Clearances by Accurate Surgical Instruments Co.

    K Number Device Name
    K950042 SWAN NECK PRESTERNAL PERITONEAL DIALYSIS CATHETER
    K920515 INSERTION
    K910786 TROCAR (FALLER STYLET)
    K910787 TITANIUM CONNECTOR (2 PART)
    K862046 SWAN-NECK PERITONEAL DIALYSIS CATHETERS
    K850214 STERILE CATHETERS-CATHETER PERITONEAL LONG-TERM IN
    K813488 CATHETER REGULAR
    K813487 CATHETER BUBBLE STAND