BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇩🇪 Germany

    VENOUS BUBBLE TRAP, MODEL VBT 160; VENOUS BUBBLE TRAP WITH BIOLINE COATING, MODEL BE-VBT 160, BEQ-VBT 160

    K Number: K082412 · Decision Nov 10, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    33
    Applicant Total
    1
    Review Days
    81

    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
    VENOUS BUBBLE TRAP, MODEL VBT 160; VENOUS BUBBLE TRAP WITH BIOLINE COATING, MODEL BE-VBT 160, BEQ-VBT 160
    K Number
    K082412
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.4230
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Mapquet Cardiopulmonary AG
    Date Received
    August 21, 2008
    Decision Date
    November 10, 2008
    Product Code
    DTP
    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
    DTP Defoamer, Cardiopulmonary Bypass

    Similar 510(k) Clearances

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

    AFFINITY VARD SUB-ASSEMBLY FOR CPS (CARMEDA COATED), PURGELINE (UNCOATED), HOLDING BAG

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    COBE VVR 4000 FILTERED HARDSHELL VENOUS RESERVOIR, COBE SMARXT VVR 4000 FILTERED HARDSHELL VENOUS RESERVOIR

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    COBE SMARXT VVR 4000 FILTERED HARDSHELL VENOUS RESERVOIR

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MODIFICATION OF BARD QUANTUM CVR, MODEL H-6770VR

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    DIDECO D920, LILLIPUT 1 TWIN RESERVOIR

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    BARD QUANTUM CVR

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