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

    NEEDLE SET, A-V FISTULA

    K Number: K770699 · Decision Jun 14, 1977
    View on FDA
    Classifications
    1
    FEI Numbers
    18
    Registration Numbers
    18
    Same Product Code
    78
    Applicant Total
    6
    Review Days
    57

    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
    NEEDLE SET, A-V FISTULA
    K Number
    K770699
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5540
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Medical Disposables Intl., Inc.
    Date Received
    April 18, 1977
    Decision Date
    June 14, 1977
    Product Code
    FIE
    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
    FIE Needle, Fistula

    Similar 510(k) Clearances

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

    JMS CAVEO A.V. Fistula Needle Set

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    DORA Disposable A.V. Fistula Needle Sets

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Dimesol Disposable AV Fistula Needle Set (Non-Safety Series) and Dimesol Disposable AV Fistula Needle Set (Safety Series)

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    DORA Disposable A.V. Fistula Needle Sets

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    JMS Harmony A.V. Fistula Needle Set

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    ANGEL TIP SAFETY INTRAVASCULAR NEEDLE SET

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology
    View all

    Other Clearances by Medical Disposables Intl., Inc.

    K Number Device Name
    K771230 PERCUTANEOUS INTRODUCER SHEATH SET
    K771231 ARTEOIAL LINE KIT
    K770945 POUCH, TYVEK-POLYMYLON
    K770552 CATHETER, KIDNEY DIALYSIS, HEMO-CATH II
    K761078 HEMO-CATH I, KIDNEY DIALYSIS CATHETER