A collection of sterile devices designed to implant a cardiac occluder for the non-surgical closure of cardiac defects. The collection may include a delivery catheter/sheath, dilator, loading device, delivery cable, and additional items for the intravascula...
A collection of devices designed to implant a cardiac occluder (not included) for the non-surgical closure of cardiac defects. The collection may include a delivery catheter/sheath, dilator, loading device, delivery cable, and additional items for the intra...
A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of one or a combination of cardiac markers in a clinical specimen, using a fluorescent immunoassay method. Cardiac markers to be as...
A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of one or a combination of cardiac markers in a clinical specimen, using an enzyme immunoassay (EIA) method. Cardiac markers to be ...
A collection of sterile, invasive devices intended to provide percutaneous vascular access to enable introduction of a cardiac device/catheter (e.g., cardiac ablation catheter, pacing lead); it is not intended for sub-xiphoid access. It includes a steerable...
A collection of reagents and other associated materials intended to be used for the qualitative detection of one or a combination of cardiac markers in a clinical specimen, within a short period, relative to standard laboratory testing procedures, using an ...
A collection of devices intended to lower the core body temperature of a patient in the short term following a cardiac arrest event to induce and sustain mild hypothermia for improvement of neurological and cognitive prognoses. It typically includes blanket...
A collection of sterile devices designed to perform an intraosseous (IO) infusion (i.e., an infusion directly into the bone's medullary cavity for the purpose of administering emergency medications and other fluids). It typically consists of a needle (possi...
An assembly of devices intended to regulate a patient's body temperature by circulating a temperature-controlled fluid (e.g., saline solution) through a dedicated, closed-circuit catheter placed in the central venous system (CVS), to heat or cool the patien...
An assembly of devices intended to regulate a patient's body temperature by circulating a temperature-controlled fluid (e.g., saline solution) through a dedicated, closed-circuit catheter placed in the central venous system (CVS), to both heat and alternati...
A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of antibodies to striated muscle in a clinical specimen, using a fluorescent immunoassay method. It is used as an aid in the diagno...
A collection of sterile devices intended to assist the surgical introduction of an implantable cardiothoracic device (e.g., implantable cardiac monitor) within a subcutaneous cavity in the thorax; it is not intended for implantation within an organ (i.e., h...