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

    PACESETTER SYSTEMS, ENDOCARDIAL FIRM LEAD

    K Number: K850652 · Decision Apr 10, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    102
    Applicant Total
    96
    Review Days
    50

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    Basic Information

    Device Name
    PACESETTER SYSTEMS, ENDOCARDIAL FIRM LEAD
    K Number
    K850652
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.3620
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Pacesetter Systems
    Date Received
    February 19, 1985
    Decision Date
    April 10, 1985
    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 Pacesetter Systems

    K Number Device Name
    K910924 ENDOCARDIAL LEADS-MOD. TO THE POLYVINYLPYRROLIDONE
    K902147 ENDOCARDIAL SCREW-IN LEAD MODEL 1028T
    K900512 SIEMENS ELEMA MODELS 4020T AND 4021T ADAPTERS
    K900550 FAST-PASS ACE MODELS 1212T/1222T/1216T/1226T
    K895447 ENDOCARDIAL SCREW-IN LEAD MODEL 1020T
    K891905 CARDIOVASCULAR PERMANENT PACEMAKER ELECTRODE
    K885267 VS-1 MODEL NUMBER 251K PULSE GENERATOR
    K890547 SIEMENS ELEMA MODELS 4025 AND 4026 ADAPTERS
    K884733 AFP MODEL 262T PULSE GENERATOR
    K883087 PROLOG MP 658M PULSE GENERATOR
    Search all 96 clearances from Pacesetter Systems →