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

    ADAPTING SLEEVE KIT MODEL 4023

    K Number: K921318 · Decision Aug 3, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    102
    Applicant Total
    7
    Review Days
    137

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    Basic Information

    Device Name
    ADAPTING SLEEVE KIT MODEL 4023
    K Number
    K921318
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.3620
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Siemens-Pacesetter, Inc.
    Date Received
    March 19, 1992
    Decision Date
    August 3, 1992
    Product Code
    DTD
    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
    DTD Pacemaker Lead Adaptor

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    Other Clearances by Siemens-Pacesetter, Inc.

    K Number Device Name
    K942440 AFP CARDIAC PACING SYSTEM MODEL 283
    K925038 PACING LEAD MODEL 1188T
    K932892 PASSIVE PLUS ENDOCARDIAL PACING LEADS VAR. MODELS
    K930876 SILICONE BIPOLAR LEAD MODELS 1136T, 1142T &1146T
    K925347 MODEL 1148T TRANSVENOUS, SCREW-IN LEAD
    K920822 CARDIOVASCULAR PERMANENT PACEMAKER ELECTRODE