BEUDAMED
    FDA 510(k) FDA class 3 Substantially Equivalent 🇺🇸 United States

    CARDIAC ELECTRODE

    K Number: K760443 · Decision Aug 26, 1976
    View on FDA
    Classifications
    1
    FEI Numbers
    24
    Registration Numbers
    24
    Same Product Code
    486
    Applicant Total
    53
    Review Days
    10

    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
    CARDIAC ELECTRODE
    K Number
    K760443
    Device Class
    FDA class 3
    Clearance Type
    Traditional
    Regulation Number
    870.3680
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Meadox Medicals, Div. Boston Scientific Corp.
    Date Received
    August 16, 1976
    Decision Date
    August 26, 1976
    Product Code
    DTB
    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
    DTB Permanent Pacemaker Electrode

    Similar 510(k) Clearances

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

    BIOTRONIK ENDOCARDIAL PACING LEADS

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    PERMANENT PACING LEAD, MODEL PY2

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    PERMANENT PACING LEAD, MODEL REFINO, MODEL: REFINO-R, RU, RJU

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    MODEL 5071 MYOCARDIAL PACING LEAD

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    MODEL 4951M MYOCARDIAL UNIPOLAR LEAD

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    ELOX P 45-BP; ELOX P 53-BP; ELOX P 60-BP

    FDA 510(k)
    FDA Class 3 ·Cardiovascular
    View all

    Other Clearances by Meadox Medicals, Div. Boston Scientific Corp.

    K Number Device Name
    K953647 MS CLASSIQUE BALLOON CATHETER W/HYDROPASS COATING
    K960766 MEADOX MEDICALS, INC. EXPANDED PTFE VASCULAR GRAFT
    K962433 MEADOX EXXCEL EPTFE VASCULAR GRAFT
    K961847 HEMASHIELD VANTAGE (VASCULAR GRAFT
    K962342 HEMASHIELD FINESSE ULTRA-THIN, KNITTED CARDIOVASCULAR PATCH
    K955460 MEADOX MEDICALS, INC., EXPANDED & EXTERNALLY SUPPORTED EXPANDED PTFE VASCULAR GRAFT
    K952884 NOPROFILE OLBERT CATHETER SYSTEM BALLOON DILATATION CATHETER
    K955349 HEMASHIELD KNITTED DOUBLE VELOUR CARDIOVASCULAR FABRIC
    K953298 MS CLASSIQUE BALLOON DIATATION CATHETER
    K954848 HEMASHIELD MICROVEL VELOUR KNITTED VASCULAR GRAFT
    Search all 53 clearances from Meadox Medicals, Div. Boston Scientific Corp. →