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

    IVT GUIDING CATHETER

    K Number: K911869 · Decision Oct 16, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    276
    Registration Numbers
    277
    Same Product Code
    889
    Applicant Total
    12
    Review Days
    173

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    Basic Information

    Device Name
    IVT GUIDING CATHETER
    K Number
    K911869
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1250
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Intensive Technology, Inc.
    Date Received
    April 26, 1991
    Decision Date
    October 16, 1991
    Product Code
    DQY
    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
    DQY Catheter, Percutaneous

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    Other Clearances by Intensive Technology, Inc.

    K Number Device Name
    K922970 INTRA-OPERATIVE TEC ATHERECTOMY SYSTEM
    K912664 TEC ROTATING DUAL HEMOVALVE
    K903463 IVT INTRODUCER SHEATH
    K904003 HEMOCHRON(R) HEPARIN RESPONSE TEST
    K901767 MODIFIED IVT PERIPHERAL ATHERECTOMY
    K896403 MODIFIED IVT PERIPHERAL ATHERECTOMY SYSTEM
    K895903 IVT 0.014 GUIDE WIRE
    K892209 APTT BY HEMOCHRON(R)
    K890515 PERIPHERAL ATHERECTOMY SYSTEM
    K882804 0.014 PERIPHERAL GUIDE WIRE
    Search all 12 clearances from Intensive Technology, Inc. →