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

    FC-101 FEMORAL CATHETER GUIDE WIRE

    K Number: K891764 · Decision Apr 7, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    15
    Applicant Total
    36
    Review Days
    14

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    Basic Information

    Device Name
    FC-101 FEMORAL CATHETER GUIDE WIRE
    K Number
    K891764
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5540
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Akcess Medical Products, Inc.
    Date Received
    March 24, 1989
    Decision Date
    April 7, 1989
    Product Code
    LFK
    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
    LFK Catheter, Femoral

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    Other Clearances by Akcess Medical Products, Inc.

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    K930630 RIGHT ATRIAL CATHETER
    K920634 SPLITTABLE SHEATH INTRODUCER SET
    K931120 COAXIAL ACUTE CATHETER
    K914936 CONTINUOUS ARTERIOVENOUS HEMOFILTRATION CATH SET
    K920331 RIGHT ATRIAL CATHETER KITS
    K914826 AKCESS-CATH KIT
    K915215 CONTINUOUS ARTERIOVENOUS HEMOFILTRATION CATH. KITS
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