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TO ENSURE PROPER DEPLOYMENT AND USE OF THIS DEVICE AND TO PREVENT INJURY TO PATIENTS, READ ALL INFORMATION CONTAINED IN THESE INSTRUCTIONS
FOR USE.
CAUTION: Federal law restricts this device to sale by or on the order of a physician.
The instructions for use is recyclable. Dispose of used product and packaging following standard solid biohazard waste procedures.
DEVICE DESCRIPTION
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INDICATIONS
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procedures or interventional procedures using an 8 French or smaller procedural sheath for the 8F Angio-Seal device and a 6 French or smaller procedural sheath for the 6F Angio-Seal
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CONTRAINDICATIONS
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WARNINGS
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• Do not use the Angio-Seal device if the procedure sheath has been placed through the superficial femoral artery and into the profunda femoris as this may result in collagen
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PRECAUTIONS
Special Patient Populations
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Procedure
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If the Angio-Seal device does not anchor in the artery due to improper orientation of the anchor or patient vascular anatomy, the absorbable components and delivery system should be
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If repuncture at the same location of previous Angio-Seal device use is necessary in
90 days , re-entry 1 cm proximal to the previous access site can be performed safely, based on
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Restick following
initial Angioseal use
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The use of the Angioseal device for
femoral artery closure.
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