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

    INTERSEPT* OXYGEN GAS LINE FILTER

    K Number: K882136 · Decision Aug 11, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    103
    Registration Numbers
    103
    Same Product Code
    128
    Applicant Total
    15
    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
    INTERSEPT* OXYGEN GAS LINE FILTER
    K Number
    K882136
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.3300
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Medtronic Blood Systems, Inc.
    Date Received
    May 20, 1988
    Decision Date
    August 11, 1988
    Product Code
    KRD
    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
    KRD Device, Vascular, For Promoting Embolization

    Similar 510(k) Clearances

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

    HARBOR Occlusion Device

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    LOBO Vascular Occlusion System

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Concerto Versa™ Detachable Coil

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Tembo Embolic System

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    OBSIDIO™ Conformable Embolic (M0013972101010)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Polyvinyl Alcohol Embolic Microspheres

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

    Other Clearances by Medtronic Blood Systems, Inc.

    K Number Device Name
    K944966 UNIPOLAR ATRIAL TEMPORARY PACING LEAD,MODEL 6492
    K944957 TEMPORARY MYOCARDIAL PACING LEAD, MODEL 6500
    K893207 CLOSED CHEST SUPPORT CIRCUIT
    K893678 DURAN FLEXIBLE ANNULOPLASTY RING & OBTURATOR H601H
    K891687 EXTRACORPOREAL CIRCUIT WITH BIO-ACTIVE SURFACE
    K891230 MAXIMA* HOLLOW FIBER OXYGENATOR W/FILTERED RESERV.
    K885154 INTERSEPT* CRYSTALLOID CARDIOPLEGIA DELIV. SYSTEM
    K884390 INTERSEPT* CRYSTALLOID CARDIOPLEGIA FILTER
    K884244 INTERSEPT* PREBYPASS FILTER
    K883439 INTERSEPT*CRYSTALLOID CARDIOPLEGIA DELIVERY SYSTEM
    Search all 15 clearances from Medtronic Blood Systems, Inc. →