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

    ACKRAD ESOPHAGEAL BALLOON CATHETER SET

    K Number: K952542 · Decision Apr 23, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    34
    Registration Numbers
    34
    Same Product Code
    89
    Applicant Total
    42
    Review Days
    336

    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
    ACKRAD ESOPHAGEAL BALLOON CATHETER SET
    K Number
    K952542
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.1880
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Ackrad Laboratories
    Date Received
    May 23, 1995
    Decision Date
    April 23, 1996
    Product Code
    BZC
    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
    BZC Calculator, Pulmonary Function Data

    Similar 510(k) Clearances

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

    STS

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Vyntus/SentrySuite Product Line

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Vyntus BODY

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Vyntus ONE with CART, Vyntus ONE PFT only with CART, Vyntus ONE with adjustable CART, Vyntus ONE PFT only with adjustable CART

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    COSMED K5 Wearable Metabolic Technology

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    MiniBox +

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

    Other Clearances by Ackrad Laboratories

    K Number Device Name
    K021272 SIB CATHETER, MODEL 61-7005
    K020954 H/S PROCEDURE TRAY (5F), H/S PROCEDURE TRAY (7F), H/S ELLIPTOSPHERE PROCEDURE TRAY & MULTIPURPOSE PROCEDURE TRAY
    K020951 H/S CATHETER SET (5F), MODEL 61-5005; H/S CATHETER SET (7F), MODEL 61-5007
    K970492 INTRAUTERINE INSEMINATION AND SONOHYSTEROGRAPHY CATHETER
    K961752 H/S CATHETER SET(61-3005, 61-3007, 61-3605, 61-3607)
    K940176 ACKRAD IUI SET FOR INTRAUTERINE INSEMINATION
    K953034 H/S CATHETER SET(61-3005, 61-3007, 61-3605, 61-3607)
    K915813 ACKRAD ERCP CONTRAST DELIVERY SET
    K904499 NICOS (NON-INVASIVE CARDIAC OUTPUT SYSTEM)
    K911780 INFANT NASAL CANNULAE ASSEMBLY, MODIFIED
    Search all 42 clearances from Ackrad Laboratories →