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Starter™ Guidewire

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.

INTENDED USE

Starter guidewires are designed for percutaneous vessel entry using the Seldinger technique to facilitate subsequent introduction(s) of an intravascular device.

WARNINGS

Vessel trauma may result from the improper use of this device. Follow the enclosed directions carefully.

PRECAUTIONS

Starter™ guidewires should be used only by physicians thoroughly trained in interventional procedures.

ADVERSE EVENTS

Other potential adverse reactions which may result from the improper use of this device include, but are not limited to:

• Air embolism

• Hematoma at the puncture site

• Infection and perforation of the vessel

• Vessel spasm

• Hemorrhage

• Vascular thrombosis

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