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510(k) Data Aggregation

    K Number
    K122661
    Device Name
    VITAL 5 RELEAF CATHETER
    Manufacturer
    VITAL 5
    Date Cleared
    2013-02-27

    (180 days)

    Product Code
    BSO, GCY, PRE
    Regulation Number
    868.5120
    Why did this record match?
    Applicant Name (Manufacturer) :

    VITAL 5

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ReLeaf catheters are indicated for use where a routine drainage tube is required to drain fluids and exudates during or after surgery. The additional lumens allow for application of anesthetic to relieve postoperative pain.
    Device Description
    The ReLeaf catheter is comprised of a radiopaque multi-lumen catheter which bifurcates proximally into a single lumen wound drain line and a single lumen anesthetic infusion line. The distal tip of the device is composed of a thin film with one side for anesthetic infusion and the other for wound drainage. The anesthetic infusion and drainage sides of the catheter are clearly marked and mid-shaft depth markings are also present. Proximally the infusion and drain lines are both affixed to an insertion trocar.
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