Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K122735
    Device Name
    SORIN VASCULOOP TWO TIE ENDOSCOPIC LIGATION SYSTEM MODEL DTTS2
    Date Cleared
    2013-05-21

    (257 days)

    Product Code
    Regulation Number
    878.5000
    Why did this record match?
    Applicant Name (Manufacturer) :

    SORIN GROUP USA INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Sorin VascuLoop is used for proximal and distal ligation of vessels during endoscopic vessel harvesting procedures.
    Device Description
    The VascuLoop Two Tie Endoscopic Ligation System is used during endoscopic vessel harvesting to ligate both ends of the vessel being harvested at the sites where it is to be cut. The cannula allows the ligation loops to be placed and tightened from a single central incision. The product consists of a nylon cannula, tapered at both ends, with a braided polyester suture (B. Braun/Aesculap PremiCron®, 510(k) cleared by K012201) that has a closable loop tied in one end with the free end through the cannula. This assembly is packaged in a paper envelope and sealed in a Tyvek - polv coextrusion pouch with appropriate labeling. The product will be sterilized using Ethylene Oxide gas.
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1