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510(k) Data Aggregation

    K Number
    K022895
    Device Name
    ELCAM STOPCOCKS AND MANIFOLDS
    Manufacturer
    MEDICAL DEVICE CONSULTANTS, INC.
    Date Cleared
    2002-10-18

    (45 days)

    Product Code
    FMG
    Regulation Number
    880.5440
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDICAL DEVICE CONSULTANTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Elcam Stopcocks and Manifolds are indicated for fluid flow directional control and for providing access port(s) for administration of solutions. Typical uses include pressure monitoring, intravenous fluid administration and transfusion.
    Device Description
    Elcam Stopcocks and Manifolds are composed of a body with two or three ports and a handle. Each port has either a male or female connector. Male connectors also include a nut for locking over the female connector of another component. A small amount of lubricant is applied between the stopcock body and handle. Elcam Stopcocks and Manifolds will be available in a wide variety of configurations for use according to the particular situation and the clinician's preference.
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    K Number
    K002699
    Device Name
    PARIETEX COMPOSITE (PCO) MESH
    Manufacturer
    MEDICAL DEVICE CONSULTANTS, INC.
    Date Cleared
    2001-02-15

    (169 days)

    Product Code
    FTL
    Regulation Number
    878.3300
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDICAL DEVICE CONSULTANTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K002116
    Device Name
    S3 CARDIOPLEGIA CONTROL MODULE VERSION 2.0
    Manufacturer
    MEDICAL DEVICE CONSULTANTS, INC.
    Date Cleared
    2000-08-09

    (27 days)

    Product Code
    DTQ
    Regulation Number
    870.4220
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDICAL DEVICE CONSULTANTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K000551
    Device Name
    IMAGE X-70 PLUS DENTAL X-RAY UNIT
    Manufacturer
    MEDICAL DEVICE CONSULTANTS, INC.
    Date Cleared
    2000-03-16

    (27 days)

    Product Code
    EHD
    Regulation Number
    872.1800
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDICAL DEVICE CONSULTANTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K974164
    Device Name
    SWISS LITHOCLAST MASTER HANDPIECE AND 3.2 MM PROBE
    Manufacturer
    MEDICAL DEVICE CONSULTANTS, INC.
    Date Cleared
    1997-12-18

    (43 days)

    Product Code
    FFK
    Regulation Number
    876.4480
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDICAL DEVICE CONSULTANTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The LITHOCLAST® MASTER Handpiece and the 3.2 mm probe have the same intended use as their predicate accessories, that is, for the fragmentation of urinary tract calculi, including renal, ureteral and bladder stones, through rigid or The 3.2 mm probe is specifically indicated for use in semirigid endoscopes. fragmenting large stones in the bladder and kidney.
    Device Description
    MASTER Handpiece: The MASTER Handpiece is 18 mm in diameter, 228 mm long, and is constructed of aluminum alloy. The proximal end of the handpiece is connected to the LITHOCLAST pressure regulator. The chosen treatment probe is attached to the distal end of the handpiece using a screw cap. The metal projectile inside the handpiece is driven forward by the pressure from the pressure regulator. The energy from the projectile is transmitted to the probe by a shock transmitter at the distal end of the handpiece. The handpiece is sealed at both the distal and proximal ends, which: (1) prolongs the life time of the handpiece by preventing dirt, moisture and other particles from entering the handpiece; and (2) allows for the changing of probes during a treatment without the risk of breaking sterility. 3.2 mm Probe: The 3.2 mm probe is a rigid Type 304 surgical grade stainless steel rod that acts to couple the shockwave from the handpiece to the target stone. The probe is reusable and may be sterilized by steam sterilization according to standard hospital procedures.
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