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

    CARDIOVASCULAR PRESSURE MEASUREMENT (CPM) SYSTEM, NAVVUS CATHETER

    K Number: K132474 · Decision Jan 30, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    64
    Registration Numbers
    64
    Same Product Code
    63
    Applicant Total
    7
    Review Days
    176

    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
    CARDIOVASCULAR PRESSURE MEASUREMENT (CPM) SYSTEM, NAVVUS CATHETER
    K Number
    K132474
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2870
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Acist Medical Systems
    Date Received
    August 7, 2013
    Decision Date
    January 30, 2014
    Product Code
    DXO
    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
    DXO Transducer, Pressure, Catheter Tip

    Similar 510(k) Clearances

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

    OptoMonitor 3

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    OptoMonitor 3

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ACIST RXi System (016616); ACIST Navvus II Catheter (016675_

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    TruWave Disposable Pressure Transducer

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    OptoMonitor 3

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    OptoMonitor 3

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

    Other Clearances by Acist Medical Systems

    K Number Device Name
    K020892 ACIST GENTOO CONTRAST INJECTION SYSTEM
    K021015 ACIST PLUS 4 ANGIOGRAPHIC CATHETER
    K991103 MODIFICATION TO ACIST CL 100H
    K000013 ACIST ANGIOGRAPHIC INJECTION SYSTEM, MODEL R-2000
    K993774 ACIST ANGIOGRAPHIC INJECTION SYSTEM, MODEL CL1OOH
    K984058 ACIST INJECTOR SYSTEM, MODEL CL100 H