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

    GUARDWIRE TEMPORARY OCCLUSION AND ASPIRATION SYSTEM- CAROTID

    K Number: K072990 · Decision Oct 31, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    26
    Registration Numbers
    26
    Same Product Code
    35
    Applicant Total
    209
    Review Days
    7

    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
    GUARDWIRE TEMPORARY OCCLUSION AND ASPIRATION SYSTEM- CAROTID
    K Number
    K072990
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1250
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Medtronic, Inc.
    Date Received
    October 24, 2007
    Decision Date
    October 31, 2007
    Product Code
    NTE
    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
    NTE Temporary Carotid Catheter For Embolic Capture

    Similar 510(k) Clearances

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

    EmPro EPS (EP4514C-190, EP6514C-190);Nanoparasol EPS (PNP4514C-190,PNP6514C-190)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ENROUTE® Transcarotid Neuroprotection System

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ANGIOGUARD XP Emboli Capture Guidewire, ANGIOGUARD RX Emboli Capture Guidewire

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    WIRION Embolic Protection System

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    WIRION

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Emboshield NAV6 Embolic Protection System, Barewire Filter Delivery Wires

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

    Other Clearances by Medtronic, Inc.

    K Number Device Name
    K260195 Elongated One-Piece Arterial (EOPA) 3D™ Arterial Cannulae
    K253203 Retrograde Coronary Sinus Perfusion Cannulae
    K253998 Clearview Intracoronary Shunts
    K251831 Bio-Medicus Life Support Catheter and Introducer
    K253511 Concerto Versa™ Detachable Coil
    K253409 C320LBB Delivery System (C320LBBS45), C320LBB Delivery System (C320LBBS48), C320LBB Delivery System (C320LBBL45), C320LBB Delivery System (C320LBBL48)
    K251258 MC2™ Two-Stage Venous Cannula; MC2X™ Three-Stage Venous Cannula
    K250075 Medtronic Stedi Extra Support Guidewire
    K250199 VitalFlow Console
    K250558 SelectSite C304 Deflectable Catheter System (C304); C315 Delivery System (C315)
    Search all 209 clearances from Medtronic, Inc. →