Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K170958
    Device Name
    ChitoPulse 9in / 23 cm, ChitoPulse 12in / 30.5 cm, ChitoPulse 15in / 38 cm
    Date Cleared
    2017-08-29

    (151 days)

    Product Code
    Regulation Number
    870.4450
    Why did this record match?
    Applicant Name (Manufacturer) :

    Tricol Biomedical Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    ChitoPulse™ Radial Hemostatic Device is intended to promote hemostasis following a catheterization or other puncture into a blood vessel in a patient's radial artery, including arterial or venous line or sheath removal, hemodialysis and in patients on anticoagulation therapy. ChitoPulse™ Hemostatic Device is intended to promote hemostasis following a catheterization or other puncture into a blood vessel in a patient's leg, including dorsalis pedis or tibial blood vessels, arterial or venous line or sheath removal and in patients on anticoagulation therapy.
    Device Description
    ChitoPulse™ is a mechanical compression band incorporating a hemostatic chitosan patch. The compression band and chitosan patch are positioned over the radial access site and secured in place by a strap fastener. Addition of air to the compression band balloon provides rapid bleeding control by localized compression. The chitosan patch provides adjunct bleeding control to the balloon compression and provides a barrier against bacterial penetration by a wide range of gram positive and gram negative organisms. Compression is applied or reduced using a syringe and luer lock valve to add or remove air volume to or from the balloon. Once hemostasis has been achieved, compression may be reduced by gradual removal of air from the balloon. ChitoPulse™ is a single use device. Once hemostasis is achieved, the compression band is intended to be removed leaving the hemostatic chitosan patch in place. The hemostatic chitosan patch can be secured in place with a securement dressing for up to 24 hrs.
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1