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

    ACIST HDi System, ACIST Kodama Intravascular Ultrasound Catheter

    K Number: K193183 · Decision Mar 20, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    94
    Registration Numbers
    94
    Same Product Code
    77
    Applicant Total
    16
    Review Days
    123

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    Basic Information

    Device Name
    ACIST HDi System, ACIST Kodama Intravascular Ultrasound Catheter
    K Number
    K193183
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.1200
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Acist Medical Systems, Inc.
    Date Received
    November 18, 2019
    Decision Date
    March 20, 2020
    Product Code
    OBJ
    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
    OBJ Catheter, Ultrasound, Intravascular

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    Other Clearances by Acist Medical Systems, Inc.

    K Number Device Name
    K252653 ACIST Pro Diagnostic System (019304); Processing Unit Bed Mount; AngioTouch Module; ACIST Pro Cart; Single Transducer Cable; Triple Transducer Cable
    K252638 VeraPro S100 Multi-Use Syringe (018808); VeraPro S100 LV1 Low Viscosity Single-Use Syringe (018811); VeraPro AMT Auto-Manifold and Transducer (018814); VeraPro AngioTouch FLX165 Hand Controller Kit (018806); VeraPro AngioTouch HiFi165 Hand Controller Kit (018804)
    K233904 ACIST RXi System (016616); ACIST Navvus II Catheter (016675_
    K203004 ACIST CVi1 Contrast Delivery System, ACIST CVi Contrast Delivery System
    K190473 ACIST RXi System and Navvus II Catheter
    K191060 ACIST CVI1 Contrast Delivery System, A1000 Syringe Kit, A1000V Syringe Kit, BT2000 Manifold Kit, BT2000 Manifold Kit, AngioToiuch Hand Controller Kit
    K191175 ACIST Kodama Intravascular Ultrasound Catheter, ACIST HDi System
    K171646 ACISTCVi® Contrast Delivery System
    K173063 ACIST Kodama Intravascular Ultrasound Catheter, ACIST HDi System
    K172216 ACIST RXi Mini System
    Search all 16 clearances from Acist Medical Systems, Inc. →