Thruway™ Guidewire .014" & .018"

Indications, Safety, and Warnings

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CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician. Rx only. Prior to use, please see the complete “Directions for Use” for more information on Indications, Contraindications, Warnings, Precautions, Adverse Events, and Operator’s Instructions.

Thruway .014 Guidewire

INTENDED USE/ INDICATIONS FOR USE

The Thruway Guidewire facilitates placement of a catheter during diagnostic or interventional peripheral intravascular procedures including but not limited to renal intervention. The wire can be torqued to facilitate navigation through the vasculature.

CONTRAINDICATIONS

• Not intended for use in coronary arteries.

• Not intended for use in the neurovasculature.

WARNINGS/ADVERSE REACTIONS

The complications that may result from the use of a guidewire in a procedure include:

• Vessel perforation, dissection, trauma or damage

• Embolism

• Hematoma

• Infection

• Vessel spasm

• Hemorrhage

• Renal Failure

• Myocardial Infarction

• Vascular thrombosis

• Stroke

• Death

Thruway .018 Guidewire

INTENDED USE

The Thruway™ Guidewire facilitates placement of a catheter during diagnostic or interventional peripheral intravascular procedures including but not limited to renal intervention. The wire can be torqued to facilitate navigation through the vasculature.

CONTRAINDICATIONS

• Not intended for use in coronary arteries.

• Not intended for use in the neurovasculature.

ADVERSE EVENTS

The complications that may result from the use of a guidewire in a procedure include:

• Vessel perforation, dissection, trauma or damage

• Embolism

• Hematoma

• Infection

• Vessel spasm

• Hemorrhage

• Renal Failure

• Myocardial Infraction

• Vascular thrombosis

• Stroke

• Death

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