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

    SURGISIS PERIPHERAL VASCULAR PATCH

    K Number: K001785 · Decision Dec 27, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    55
    Registration Numbers
    55
    Same Product Code
    89
    Applicant Total
    31
    Review Days
    197

    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
    SURGISIS PERIPHERAL VASCULAR PATCH
    K Number
    K001785
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.3470
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Cook Biotech, Inc.
    Date Received
    June 13, 2000
    Decision Date
    December 27, 2000
    Product Code
    DXZ
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

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

    Product Code Device Name
    DXZ Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene

    Similar 510(k) Clearances

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

    PeriBeam® Pericardial Membrane

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Vascutek Gelseal Patch, Vascutek Gelsoft Patch, Vascutek Thin Wall Carotid Patch

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PhotoFix Decellularized Bovine Pericardium

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    VascuCel

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CorMatrix Tyke

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PremiPatch PTFE Pledget

    FDA 510(k)
    FDA Class 2 ·Cardiovascular
    View all

    Other Clearances by Cook Biotech, Inc.

    K Number Device Name
    K133306 SIS HERNIA GRAFT
    K133011 DIAPHRAGMATIC HERNIA GRAFT
    K131015 BIODESIGN ONLAY DURAL GRAFT OR BIODESIGN DURAPLASTY GRAFT
    K111695 HYBRID GRAFT
    K110402 BIODESIGN NIPPLE RECONSTRUCTION CYLINDER
    K090688 COOK UROLOGICAL GRAFT
    K082682 SURGISIS BIODESIGN ENTEROCUTANEOUS FISTULA PLUG
    K082058 DYNAMATRIX
    K073391 SURGISIS BIODESIGN TISSUE GRAFT
    K070405 MODIFICATION TO SURGISIS SLR STAPLE LINE REINFORCEMENT
    Search all 31 clearances from Cook Biotech, Inc. →