AlphaVac F18⁸⁵ US Indication and Risk Information:

Indication for Use:

The F18⁸⁵ Cannula is indicated for:

• the non-surgical removal of thrombi or emboli from the vasculature
• aspiration of contrast media and other fluids from the vasculature

The Cannula is intended for use in the venous system and for the treatment of pulmonary embolism.

The Handle is indicated as a vacuum source for the AlphaVac Multipurpose Mechanical Aspiration System.

Contraindications:

The following contraindications are applicable:

• The device is contraindicated in the removal of chronic firmly adherent intravascular material.
• The device is contraindicated for use in the right heart or pulmonary arteries during active cardiopulmonary resuscitation.
• The device is contraindicated for blood storage and infusion back into the patient.

Refer to Instructions for Use and/or User Manual provided with the product for complete Instructions, Warnings, Precautions, Potential Complications and Contraindications prior to use of the product.

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CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician. US/VI/WP/2461 Rev.01 04/2024