Model TWINFLO -Catheter Indications for Use
The TwinFlo™ Catheter is intended for general intravascular use in the peripheral vasculature in arteries 3.5 mm and larger. Once placed in the selected region, the catheter can be used for infusion of diagnostic and/or therapeutic agents, and for controlling blood flow to the selected region when connected to an extracorporeal circuit. The diagnostic and/or therapeutic agents are to be used in accordance with specifications outlined by the manufacturer.
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- The TwinFlo™ Catheter is contraindicated for use in coronary and intracranial arteries.
- The TwinFlo™ Catheter is not intended for embolic protection or as an aspiration catheter.
- It is the responsibility of the physician to determine whether any physical impairment of the patient would contraindicate the use of this device.
- The TwinFlo™ Catheter is not intended to be used with a power injector.
* The TwinFlo™ Catheter is investigational for use in acute stroke