BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    ACTI-FLEX ARTERIAL EXTENSION SET

    K Number: K954035 · Decision Sep 25, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    39
    Registration Numbers
    39
    Same Product Code
    57
    Applicant Total
    7
    Review Days
    28

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    Basic Information

    Device Name
    ACTI-FLEX ARTERIAL EXTENSION SET
    K Number
    K954035
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    868.1100
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    R-Group Intl.
    Date Received
    August 28, 1995
    Decision Date
    September 25, 1995
    Product Code
    CBT
    Advisory Committee
    Anesthesiology
    Review Advisory Committee
    AN
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    CBT Arterial Blood Sampling Kit

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    Other Clearances by R-Group Intl.

    K Number Device Name
    K001233 ACTI-FLEX FLUID DELIVERY SYSTEM OR ACTI-FLEX F D S
    K001599 ACTI-FLEX IV ADMINISTRATION SET
    K993777 DISPOSABLE AND REUSABLE BALL AND LOOP ELECTRODES
    K952470 ACTI-FLEX LOW, MEDIUM, RESCARE I, RESCARE II.
    K940319 R-GROUP INTERNATIONAL COILED LOW PRESSURE EXTENSION LINE
    K913267 R-GROUP INTL. ONE WALL PUNCTURE NEEDLE