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510(k) Data Aggregation

    K Number
    K041890
    Device Name
    CRYOCOR MODEL 1250 (BREVA) SERIES SURGICAL PROBES, MODEL 1255-15-12
    Manufacturer
    Date Cleared
    2004-09-22

    (72 days)

    Product Code
    Regulation Number
    878.4400
    Why did this record match?
    Applicant Name (Manufacturer) :

    CRYOCOR, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The CryoCor Model 1255 Surgical Probe is intended to be used for the treatment of cardiac diseases, such as arrhythmia, by the application of extreme cold in order to ablate (destroy) electrically abnormal cardiac and vascular tissue. The Probe is part of a Cryoablation System, which includes a control console and a Probe/console interface. The Probe will be used under direct visualization to perform cardiac ablation procedures in the cardiac surgical setting. The intent of the device will be to treat patients either concomitant with or using techniques widely used in cardiac surgery, including thoracotomy or minimally invasive (MICS) techniques. The CryoCor Model 1250 ("Breva") Series Surgical Probes are intended to be used in thoracic surgery, specifically for the ablation of arrhythmic cardiac tissue.
    Device Description
    The CryoCor Model 1255 Surgical Probe is a single-use, disposable device that interfaces with the Cryoablation console and delivers Cryoablation therapy to the target tissue, using N2O as a cryogen and employing the Joule-Thomson effect to cause a block of electrical conduction through tissue through cryonecrosis. Placement of the Probe tip is accomplished under direct visualization by manipulation of the Probe handle (applying torque to the shaft and/or deflecting the articulation segment). The Breva Model Series may include multiple articulation lengths and multiple tip lengths. The first model of the Breva Model Series to be commercialized will be the Breva 1255-15-12 (i.e. 5cm articulation length, 15 mm tip length, and 12cm shaft length).
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    K Number
    K040552
    Device Name
    MODEL 3100 SERIES SHEATH INTRODUCER KITS, MODELS 3110, 3130
    Manufacturer
    Date Cleared
    2004-05-28

    (87 days)

    Product Code
    Regulation Number
    870.1340
    Why did this record match?
    Applicant Name (Manufacturer) :

    CRYOCOR, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The CryoCor Model 3100 Series Sheath Kits are intended to facilitate the percutaneous introduction of cardiovascular catheters into the heart, while preventing backflow of blood.
    Device Description
    The Model 3100 Series Sheath Introducer Kit consists of various sheath introducers, each packaged in a kit together with a dilator, introducer catheter and guide wire. The sheath introducer is fitted with a hemostasis valve to minimize blood loss during catheter introduction and/or exchange. A side port with three-way stopcock is provided for air aspiration, fluid infusion, blood sampling and pressure monitoring. A radioopaque marker at the tip of the sheath will aid during placement while utilizing fluoroscopic guidance. There are side holes at the distal end to allow for injection of contrast media. The dilator is tapered at the distal tip to allow for use of standard needles for trans-septal procedures, and will accommodate a guide wire or needle no larger than 0.038". The introducer catheter is gradually tapered distally to allow for gradual dilation of entry into vasculature without producing damage. The guide wire is 0.038" in diameter, 150 cm in length with a "I"-tip configuration. It is supplied in a hoop dispenser with a "J" straightener attached to the distal end. The proximal end of the hoop dispenser has a luer hub to facilitate flushing of the wire.
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