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

    SENTRA

    K Number: K843060 · Decision Sep 20, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    102
    Applicant Total
    76
    Review Days
    48

    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
    SENTRA
    K Number
    K843060
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.3620
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Cardiac Pacemakers, Inc.
    Date Received
    August 3, 1984
    Decision Date
    September 20, 1984
    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 Cardiac Pacemakers, Inc.

    K Number Device Name
    K093969 ACUITY BREAK-AWAY GUIDE CATHETER
    K080154 ACUITY UNIVERSAL CUTTER
    K934727 REPLACEMENT PARTS FOR CPI 6888 LEAD TUNNELER
    K920601 ASTRA T2, ASTRA T4, ASTRA T6
    K912379 PDT CARRYALL TRANSMITTER, VARIOUS MODELS
    K905674 LEAD STYLET
    K900498 MODIFIED BETATRON IV INSULIN INFUSION SYSTEM
    K894738 MODEL 6888 LEAD TUNNELER
    K890785 ASTRA T2, T3, T4, T6 PULSE GENERATORS NEW PACKAGE
    K875147 TORQUE HEX WRENCH
    Search all 76 clearances from Cardiac Pacemakers, Inc. →