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The 091 Balloon Guide Catheter is infacilitating the insertion and guidance of intravascular catheters into a selected blood vessel in the peripheral and neuro vascular systems. The balloon provides temporary vascular occlusion during these and other angiographic procedures. The Balloon Guide Catheter is also indicated for use as a conduit for Retrieval devices.

The 091 Balloon Guide Catheter is a coaxial-lumen, coil-reinforced, variable stiffness catheter with a balloon at the distal end. A radiopaque marker is included at the distal end of the distal tip of the catheter) for fluoroscopic visualization. A compliant balloon is flush mounted on the catheter to provide temporary vascular occlusion during angiographic procedures. A bifurcated luer hub on the proximal end of the catheter allows attachments for flushing, and aspiration. This catheter is designed for use in facilitating the insertion and guidance of an intravascular catheter into a selected blood vessel in the peripheral and neuro vascular systems. The dimensions and maximum recommended balloon inflation volume for the 091 Balloon Guide Catheter are indicated on the product label. A peel-away introducer, dilator, and one-way luer valve accessory are included within the packaging. A similar dilator was cleared as part of the reference device under K172468. The 091 Balloon Guide Catheter is supplied sterile, non- pyrogenic, and is intended for single use only.