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

    AVD INTIMAX OCCLUSION CATHETER

    K Number: K910339 · Decision May 29, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    11
    Applicant Total
    21
    Review Days
    121

    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
    AVD INTIMAX OCCLUSION CATHETER
    K Number
    K910339
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1370
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Applied Vascular Devices, Inc.
    Date Received
    January 28, 1991
    Decision Date
    May 29, 1991
    Product Code
    DQT
    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
    DQT Occluder, Catheter Tip

    Similar 510(k) Clearances

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

    GT1 FLOPPY, GT1 HI-PER FLEX, GT1 LIGHT SUPPORT

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    THE OMNIGUIDE GUIDING CATHETER WITH BALLOON

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CATHLAB SILICONE OCCLUSION BALLOON CATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CORONARY OSTIUM OCCLUDER, CATALOG CODE 32015

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MODIFIED PRUITT IRRIGATION & OCCLUSION CATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    THE ROBICSEK - PRUITT AORTIC BALLOON OCCLUSION KIT

    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
    K910372 INTIMAX THROMBECTOMY 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. →