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

    IS-1/QUADRIPOLAR TERMINAL CAP, PART NUMBER 6011069

    K Number: K950140 · Decision Apr 6, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    102
    Applicant Total
    8
    Review Days
    83

    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
    IS-1/QUADRIPOLAR TERMINAL CAP, PART NUMBER 6011069
    K Number
    K950140
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.3620
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Pacesetter, Inc.
    Date Received
    January 13, 1995
    Decision Date
    April 6, 1995
    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

    Similar 510(k) Clearances

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

    IS4/DF4 Port Plug

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    6981M LEAD EXTENDER KIT, 6984M LEAD EXTENDER KIT, 6986M LEAD EXTENDER KIT, 5866-24M LEAD ADAPTOR KIT, 5866-38M LEAD ADAP

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CPI LEAD ADAPTERS, MODELS 6017, 6018 AND 6020

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PACING LEAD ADAPTORS, BIPOLAR, MODELS ILINK-BIS, ILINK-BLV

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PACING LEAD EXTENSIONS, BIPOLAR, PACING LEAD ADAPTORS, UNIPOLAR/BIPOLAR,PACING LEAD ADAPTORS, UNIPOLAR/BIPOLAR

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PACING LEAD BIPOLAR ADAPTERS AND EXTENSIONS

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

    Other Clearances by Pacesetter, Inc.

    K Number Device Name
    K972814 LOCATOR MODEL 4036
    K960854 SIEMENS SERVO ULTRA NEBULIZER 345
    K954714 AFP CARDIAC PACING SYSTEM MODEL 283 (MODIFICATION)
    K954551 DF-1 TERMINAL CAP
    K951950 PASSIVE PLUS PACING LEADS WITH TITANIUM NITRIDE COATING
    K952206 PASSIVE PLUS PACING LEADS WITH TITANIUM NITRIDE COATING
    K951087 TENDRIL, UNIPOLAR ENDOCARDIAL SCREW-IN LEAD