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

    STERILE CATHETERS-CATHETER PERITONEAL LONG-TERM IN

    K Number: K850214 · Decision Jul 26, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    26
    Registration Numbers
    26
    Same Product Code
    47
    Applicant Total
    9
    Review Days
    185

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    Basic Information

    Device Name
    STERILE CATHETERS-CATHETER PERITONEAL LONG-TERM IN
    K Number
    K850214
    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
    January 22, 1985
    Decision Date
    July 26, 1985
    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)
    K910785 TITANIUM CATHETER EXTENDER
    K910787 TITANIUM CONNECTOR (2 PART)
    K862046 SWAN-NECK PERITONEAL DIALYSIS CATHETERS
    K813488 CATHETER REGULAR
    K813487 CATHETER BUBBLE STAND