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

    MODIFIED IVT PERIPHERAL ATHERECTOMY SYSTEM

    K Number: K896403 · Decision Mar 6, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    92
    Registration Numbers
    92
    Same Product Code
    402
    Applicant Total
    12
    Review Days
    119

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    Basic Information

    Device Name
    MODIFIED IVT PERIPHERAL ATHERECTOMY SYSTEM
    K Number
    K896403
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1250
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Intensive Technology, Inc.
    Date Received
    November 7, 1989
    Decision Date
    March 6, 1990
    Product Code
    LIT
    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
    LIT Catheter, Angioplasty, Peripheral, Transluminal

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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
    K911869 IVT GUIDING CATHETER
    K903463 IVT INTRODUCER SHEATH
    K904003 HEMOCHRON(R) HEPARIN RESPONSE TEST
    K901767 MODIFIED IVT PERIPHERAL ATHERECTOMY
    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. →