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

    AUTOMATIC TUBING CLAMP SYSTEM (ATC)

    K Number: K961364 · Decision Oct 31, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7
    Same Product Code
    13
    Applicant Total
    5
    Review Days
    205

    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
    AUTOMATIC TUBING CLAMP SYSTEM (ATC)
    K Number
    K961364
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.4205
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Rocky Mountain Research, Inc.
    Date Received
    April 9, 1996
    Decision Date
    October 31, 1996
    Product Code
    KRL
    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
    KRL Detector, Bubble, Cardiopulmonary Bypass

    Similar 510(k) Clearances

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

    STOCKERT AIR PURGE CONTROL SYSTEM MODEL 23-45-05

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CAPIOX BUBBLE TRAP WITH X-COATING

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    EDAC QUANTIFIER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ELS AUTOMATIC TUBING CLAMP SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SARNS ULTRASONIC AIR SENSOR

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SARNS AIR DETECTION SYSTEM

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

    Other Clearances by Rocky Mountain Research, Inc.

    K Number Device Name
    K992857 LEVELSENS - FLEXIBLE, MODEL 201110, LEVELSENS - RIGID, MODEL 201070
    K961598 ELS AUTOMATIC TUBING CLAMP SYSTEM
    K921993 ELS AUTOMATIC TUBING CLAMP SYSTEM
    K914459 AUTOMATIC TUBING CLAMP