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

    PULSION PULSIOCATH THERMODILUTION CATHETERS & ACCESSORIES

    K Number: K072364 · Decision Sep 19, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    49
    Registration Numbers
    49
    Same Product Code
    36
    Applicant Total
    5
    Review Days
    28

    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
    PULSION PULSIOCATH THERMODILUTION CATHETERS & ACCESSORIES
    K Number
    K072364
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.1915
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Pulsion Medical Systems AG
    Date Received
    August 22, 2007
    Decision Date
    September 19, 2007
    Product Code
    KRB
    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
    KRB Probe, Thermodilution

    Similar 510(k) Clearances

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

    PiCCO Catheter

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    VOLUMEVIEW SYSTEM, MODELS VLV520FT6R, VLV520FT8R, VLV520FT6R5

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PULSION PULSIOCATH PICCO MONITORING KIT, INJECTATE SENSOR TEMPERATURE HOUSING PV 4046

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PULSION PULSIOCATH, PULSION PCCO MONITORING KIT, PULSION IN-LINE INJECTATE SENSOR

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CRITIKIT PLUS IN LINE ROOM/ICE TEMPERATURE INJECTATE KIT

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PACEVIEW

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

    Other Clearances by Pulsion Medical Systems AG

    K Number Device Name
    K091786 PULSION PICCO2 (8500), CEVOX OPTICAL MODULE (PC3015), CEVOX DISPOSABLE PROBES (PV2022-30 THRU -38, PV2022-46 THRU -48)
    K072735 PULSION PICCO-2, MODEL 8500
    K060898 PULSION PICCO PLUS, MODEL 8100
    K020587 PULSION PULSIOCATH PICCO MONITORING KIT, INJECTATE SENSOR TEMPERATURE HOUSING PV 4046