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

    OCCLUSION BALLOON CATHETER

    K Number: K960832 · Decision May 29, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    62
    Registration Numbers
    62
    Same Product Code
    89
    Applicant Total
    28
    Review Days
    90

    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
    OCCLUSION BALLOON CATHETER
    K Number
    K960832
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.4450
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Interventional Therapeutics Corp.
    Date Received
    February 29, 1996
    Decision Date
    May 29, 1996
    Product Code
    MJN
    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
    MJN Catheter, Intravascular Occluding, Temporary

    Similar 510(k) Clearances

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

    pREBOA-PRO Catheter

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Bridge Plus Occlusion Balloon (590-002)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    preCARDIA Occlusion System

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    LANDMARK REBOA Catheter

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Fogarty Occlusion Catheter

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    RenovoCath

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

    Other Clearances by Interventional Therapeutics Corp.

    K Number Device Name
    K950398 CATHETER, BALLOON TYPE
    K945588 DISPOSABLE 1CC SYRINGE WITH LUER LOCK
    K944354 CONTOUR EMBOLI
    K930456 INTHERM SINGLE-STICK RADIALLY EXPANDING DILATOR
    K914866 ITC CONTOUR EMBOLI, MODIFICATION
    K931025 INTHERM STASIS VALVE SYSTEM
    K931278 INTHERM SINGLE-STICK RADIALLY EXPANDING DILATOR
    K922609 ITC CATHETERS W/ HYDROMER
    K925876 ITC BUNJI PLATINUM EMBOLIZATION COIL
    K925523 ITC BUNJI PLATINUM EMBOLIZATION COIL
    Search all 28 clearances from Interventional Therapeutics Corp. →