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The Bipore Accuflex™ Percutaneous Sheath Introducer is recommended for percutaneous introduction of various devices into arteries and/or veins for diagnostic and therapeutic procedures.

The Bipore Accuflex™ Percutaneous Sheath Introducer is a flexible tube designed for the percutaneous introduction of various devices into arteries and/or veins for a variety of diagnostic and therapeutic procedures. The product consists of a tube fabricated out of nylon based, flouropolymer lined material, reinforced by a flexible stainless steel wire within the tube. Proximally located on the flexible tube is an integral side port/hemostasis valve and/or female luer connection for attachment to a Touhy Borst adaptor. The side port, which provides a means of introducing contrast media or other fluids, is fabricated from non-DEHP PVC. The hemostasis valve is made from silicone rubber. The Touhy Borst adapter is a separate or connected component purchased from B.Braun. This purchased component is used in a manner consistent with B.Braun specification and premarket clearance. The proximal end contains a 24 karat gold radiopaque marker. The stainless steel coil enables the introducer to kink resistant during normal use. The proximal end may also contain a 45° to 180° radius bend. This pre-bend allows the product to be directed by transferring distal torque to steer the proximal tip. The reinforced tube, through which a vessel dilator or catheter is introduced is available in 5,6,7 and 8 French sizes and in lengths ranging from 5 cm to 110 cm.

The Bipore AccuFlex ™ Percutaneous Sheath Introducer is recommended for The Dipore Acour Ion and therapeutic procedures. The Bipore AccuFlex ™ Percutaneous Sheath Introducer is indications for 500: The Diperty of various devices into arteries and/or veins for diagnostic and therapeutic procedures.

Bipore Accuflex™ Percutaneous Sheath Introducer

The Bipore Balloon Dilation Catheter is intended to be used for multations for out. The Bipos Daily of the iliac, femoral and renal arteries, and for perculariedus thanslaminar angloplace, or the autologous or synthetic arteriovenous dialysis fistulae.

The Bipore Inc. Balloon Dilation Catheter is an over-the-wire double lumen balloon catheter designed for percutaneous transluminal angioplasty (PTA) in peripheral arteries, including iliac, femoral, and renal arteries. The catheter consists of a 5 French nylon-based shaft with two lumens. One lumen is for inflation and deflation of the balloon. The other lumen accepts a guidewire for manipulation of the catheter to the site stenosis. Guidewires up to 0.035" diameter may be used. There is a bifurcated proximal juncture that provides access to each lumen. A non-compliant dilation balloon of nylon (11) is at the distal end of the catheter. When inflated, the balloon exerts a controlled radial pressure. Located under the proximal and distal ends of the balloon are radiopaque markers, which provide a reference point for locating the balloon within the vessel. A Teflon™ sleeve is placed over the deflated balloon prior to shipping. This sleeve is designed to protect the balloon in storage and is removed prior to use.

The Bipore Balloon Dilatation Catheter is recommended for percutaneous transluminal angioplasty of the iliac, femoral, and renal arteries, and for the treatment of obstructive lesions of autologous or synthetic arteriovenous dialysis fistulae. The Bipore PTA Balloon Dilatation Catheter is also indicated for post deployed stent expansion. Use of the Bipore Balloon Dilatation Catheter for post-deployed stent expansion was demonstrated on the bench with the Cordis Palmaz™ stent*.

The Bipore Balloon Dilatation catheter is a double lumen balloon catheter for percutaneous transluminal angioplasty in peripheral vessel. One lumen is for inflation and deflation of the balloon; the other lumen is used to pass the catheter over a guide wire to locate the balloon at the site of stenosis. This submission adds two balloon sizes to the existing product line, as follows, and does not affect the safety or effectiveness of the device.

The Bipore PTA catheters are indicated for percutaneous transluminal angioplasty of the illac, femoral, and renal arteries, and for the treatment of obstructive lesions of autologous or synthetic arteriovenous dialysis fistulae. The Birgore, Inc. PTA Balloon Dilatation Catheter is also indicated for post-deployed stent expansion. Use of the Signe Dilatation Catheter for post-deployment sten expansion was demonstrated on the bench with the Cordi's Palmaz™ stent *. All sterts must be implanted and deployed according to the stent manufacturer's indications, contraindications, and instructions for use.

The Bipore Balloon Dilatation Catheter is a double lumen balloon catheter for percutaneous transluminal angioplasty in peripheral vessel. One lumen is for inflation and deflation of the balloon; the other lumen is used to pass the catheter over a guide wire to locate the balloon at the sire of stenosis. This submission adds two balloon sizes to the existing product line, as follows, and does not affect the safety or effectiveness of the device.

The Bipore AccuFlex™ Percutanous Sheath Introducer is designed to be used for the percutaneous introductionn of various devices into arteries and/or veins for diagnostic and therapeutic procedures.

The Bipore AccuFlex™ Percutaneous Sheath Introducer is a wire-reinforced flexible tube with an integral side port/hemostasis valve at the proximal end.

The Bipore Balloon Dilatation Catheter is indicated for Transluminal Percutaneous Angioplasty (PTA) of the iliac, femoral, and renal arteries, and for the treatment of obstructive lesions of autologous or synthetic arteriovenous dialysis fistulae.

The Bipore Balloon Dilatation Catheter is a double lumen balloon catheter for percutaneous transluminal angioplasty in peripheral vessels. One lumen is for inflation and deflation of the balloon; the other lumen is used to pass the catheter over a guidewire to locate the balloon at the site of stenosis. The Bipore Balloon Dilatation Catheter will be offered in three balloon sizes and one shaft length, as follows: Inflated Balloon Diameter (mm): 6, 8, 10 Balloon Length (cm): 4, 4, 4 Catheter Size (Fr): 5, 5, 5 Usable Length (cm): 100, 100, 100