SK400

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<h2>Indications, Safety, and Warnings</h2> Note: 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. <h3>Amplatz Goose Neck™ snare kit</h3> <h4>Reference statement</h4> Important information: Indications, contraindications, warnings and instructions for use can be found in the product labeling supplied with each device. Indications for Use: The Amplatz Goose Neck snare is intended for use in the cardiovascular system or hollow viscus to retrieve and manipulate foreign objects. Manipulation procedures include indwelling venous catheter repositioning, indwelling venous catheter fibrin sheath stripping, and central venous access venipuncture procedure assistance. Contraindications: This device is not intended for removing foreign bodies that have become entrapped by tissue growth. This device should not be used for fibrin sheath stripping in the presence of atrial or ventricular septal defects or persistent foramen ovale. This device is not intended for removal of implanted pacing leads. Potential adverse events: Potential adverse events associated with the use of the snare include, but are not limited to embolization, myocardial infarction, stroke, indwelling catheter damage on small-bore catheters, pulmonary embolization, device entrapment, infection, lengthened procedure, vessel damage, and vessel perforation. Caution: Federal (USA) law restricts this product for sale by or on the order of a physician. FTSOP113326-48c <h3>Amplatz Goose Neck™ microsnare kit</h3> <h4>Reference statement</h4> Important information: Indications, contraindications, warnings and instructions for use can be found in the product labeling supplied with each device. Indications for use: The Amplatz Goose Neck microsnare kit is intended for use in the retrieval and manipulation of atraumatic foreign bodies located in the coronary and peripheral cardiovascular system and the extra-cranial neurovascular anatomy. Contraindications: The device is not intended for the removal of foreign bodies entrapped by tissue growth. Potential adverse events: Potential adverse events associated with the use of the microsnare include, but are not limited to embolization, myocardial infarction, stroke, pulmonary embolization, device entrapment, infection, lengthened procedure, vessel damage, and vessel perforation. Caution: Federal (USA) law restricts this product for sale by or on the order of a physician. FTSOP113326-74b

Description

The Amplatz Goose Neck™ snare and microsnare, with their 90° angled loop and nitinol design, is designed for coaxial wall apposition and ability to capture in the peripheral vasculature. Choose from a wide variety of sizes to assist with the retrieval and manipulation within large or small vessels.

The intended purpose of the Amplatz Goose Neck™ snare kit is to retrieve and manipulate foreign bodies in the cardiovascular system during interventional and manipulation procedures.

The Amplatz Goose Neck™ microsnare is intended to retrieve and manipulate atraumatic foreign bodies in the coronary and peripheral cardiovascular system and extracranial neurovascular system during interventional and manipulation procedures.

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