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

    INTIMAX THROMBECTOMY CATHETER

    K Number: K910372 · Decision Apr 26, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    33
    Registration Numbers
    33
    Same Product Code
    73
    Applicant Total
    21
    Review Days
    87

    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
    INTIMAX THROMBECTOMY CATHETER
    K Number
    K910372
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.5150
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Applied Vascular Devices, Inc.
    Date Received
    January 29, 1991
    Decision Date
    April 26, 1991
    Product Code
    DXE
    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
    DXE Catheter, Embolectomy

    Similar 510(k) Clearances

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

    Fogarty Thru-Lumen Embolectomy Catheter

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Fogarty Fortis Arterial Embolectomy Catheter

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Fogarty Arterial Embolectomy Catheter with Gate Valve

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Fogarty Venous Thrombectomy Catheters

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Fogarty Corkscrew Catheters; Fogarty Graft Thrombectomy Catheters

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Merlin Aspiration System

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

    Other Clearances by Applied Vascular Devices, Inc.

    K Number Device Name
    K911730 SURGICAL OBTURATOR WITH SEAL
    K911589 DISPOSABLE SURGICAL TROCAR WITH SEAL
    K910339 AVD INTIMAX OCCLUSION CATHETER
    K911181 INTIMAX(TM) IRRIGATION CATHETER
    K910493 AVD INTIMAX CHOLANGIOGRAPHY CATHETER
    K903848 DIAGNOSTIC INTRASCULAR CATHETER
    K905738 OPERATIVE CHOLANGIOGRAPHIC CATHETER
    K910079 DISPOSABLE INTRODUCER SHEATH
    K902256 IRRIGATION CATHETER 4, 6 AND 10 FRENCH
    K904379 SURGICAL TROCAR AND CANNULA
    Search all 21 clearances from Applied Vascular Devices, Inc. →