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

    Surefire Guiding Catheter

    K Number: K162359 · Decision Sep 21, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    276
    Registration Numbers
    277
    Same Product Code
    889
    Applicant Total
    10
    Review Days
    29

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    Basic Information

    Device Name
    Surefire Guiding Catheter
    K Number
    K162359
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.1250
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Surefire Medical, Inc.
    Date Received
    August 23, 2016
    Decision Date
    September 21, 2016
    Product Code
    DQY
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    Y

    Classifications

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

    Product Code Device Name
    DQY Catheter, Percutaneous

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    Other Clearances by Surefire Medical, Inc.

    K Number Device Name
    K180677 Surefire Spark Infusion System
    K171355 Surefire Precision Infusion System
    K160662 Surefire Infusion System
    K143588 Surefire Infusion System 021
    K140034 SUREFIRE GUIDING CATHETER
    K122506 SUREFIRE HIGH FLOW ANGIOGRAPHIC CATHETER, ACCESS
    K121677 SUREFIRE HI-FLOW MICROCATHETER
    K113737 SUREFIRE GUIDE SHEATH
    K110459 SUREFIRE INFUSION CATHETER SYSTEM