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IMPORTANT: You
are viewing the international section of
Ekoscorp.com. This section may describe clearances
in countries other than the United States, and
therefore may contain indications and information
that are outside the scope of the FDA-cleared
labeling.
The CE Mark
(CE197) has been affixed to the EkoSonic® and
MicroSonicTM products with the following indications
for use:
Indications
Peripheral Vasculature
The EkoSonic
Endovascular Device, consisting of the
Intelligent
Drug Delivery CatheterTM (IDDC) and
the MicroSonic Device (MSD), is intended for
controlled and selective infusion of
physician-specified fluids, including
thrombolytics, into the peripheral vasculature.
All therapeutic agents utilized with the
EkoSonic Endovascular System should be fully
prepared and used according to the instruction
for use of the specific therapeutic agent.
The MicroSonic SV Endovascular Device is
intended for the controlled and selective
infusion of physician specified fluids,
including thrombolytics, into the peripheral
vasculature.
Neurovasculature
The MicroSonic
SV Endovascular Device is intended for the
controlled and selective infusion of physician
specified fluids into the neurovasculature.
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