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

    INTESTOPLANT

    K Number: K862412 · Decision Nov 13, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    3
    Applicant Total
    41
    Review Days
    141

    Basic Information

    Device Name
    INTESTOPLANT
    K Number
    K862412
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5965
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    BURRON MEDICAL PRODUCTS, INC.
    Date Received
    June 25, 1986
    Decision Date
    November 13, 1986
    Product Code
    LLD
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

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

    Product Code Device Name
    LLD Port & Catheter, Implanted, Subcutaneous, Intraperitoneal

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    Other Clearances by BURRON MEDICAL PRODUCTS, INC.

    K Number Device Name
    K870403 CAVAFIX(R) CENTRAL VENOUS CATHETER KIT W/SUTURE
    K861479 CAVAFIX, CENTRAL VENOUS CATHETER KIT
    K860126 STIMUPLEX, NERVE STIMULATOR
    K851293 IMPLANTOFIX
    K841428 JEJUNOSTOMY SET FOR TUBE FEEDING
    K834383 DUAL-LUMEN LONG TERM CENTRAL VENOUS CAT
    K834299 LONG TERM CENTRAL VENOUS ACCESS CATH
    K834473 MULTI-LUMEN CENTRAL VENOUS CATH. KIT
    K840179 CONTINUOUS EPIDURAL ANESTHES. TRAY
    K840287 BRACHIAL PLEXUS ANESTHESIA TRAY
    Search all 41 clearances from BURRON MEDICAL PRODUCTS, INC. →