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

    INTIMAX(TM) IRRIGATION CATHETER

    K Number: K911181 · Decision Apr 18, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    34
    Registration Numbers
    34
    Same Product Code
    25
    Applicant Total
    21
    Review Days
    31

    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(TM) IRRIGATION CATHETER
    K Number
    K911181
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5010
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Applied Vascular Devices, Inc.
    Date Received
    March 18, 1991
    Decision Date
    April 18, 1991
    Product Code
    GCA
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    GCA Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection

    Similar 510(k) Clearances

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

    Disposable Stone Retrieval Balloon Catheter

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Stone Extraction Balloon (VDK-BAL-23-11/13/15-B,VDK-BAL-23-15/18/20-B,VDK-BAL-23-9/12/15-B,VDK-BAL-23-10/13/16-B,VDK-BAL-23-8.5/11.5/15-B,VDK-BAL-23-12/15/18-B,VDK-BAL-23-11/13/15-C,VDK-BAL-23-15/18/20-C,VDK-BAL-23-9/12/15-C,VDK-BAL-23-10/13/16-C,VDK-BAL-23-8.5/11.5/15-C,VDK-BAL-23-12/15/18-C)

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    SpyGlass Discover Balloon Dilation Catheter

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Stone Retrieval Balloon Catheter

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Stone Retrieval Balloon

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Fusion Quattro Extraction Balloon

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology
    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
    K910372 INTIMAX THROMBECTOMY 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. →