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TurboHawk™ peripheral plaque excision system

Indications, Safety, and WarningsNote: Safety information provided is for the United States. Refer to your region’s instructions for use for specific details.This therapy is not for everyone. Please consult your physician. A prescription is required. Prior to use, refer to the instructions for use supplied with these devices for indications, contraindications, side effects, suggested procedure, warnings, and precautions. Important informationIndications, contraindications, warnings, and instructions for use can be found in the product labeling supplied with each device.Indications for use The TurboHawk™ peripheral plaque excision system is intended for use in the atherectomy of the peripheral vasculature. The TurboHawk™ catheter is not intended for use in the coronary, carotid, iliac, or renal vasculature.The TurboHawk™ catheter is indicated for use in conjunction with the SpiderFX™ embolic protection device in the treatment of severely calcified lesions (LX-C only).Caution: Federal law (United States) restricts this product for sale by or on the order of a physician.FTSOP113326-66 Rev. 1C

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