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The Gatekeeper Balloon Catheter is indicated for temporary occlusion of vessels in the peripheral vasculature.

The Gatekeeper Balloon Catheter is an over the wire (OTW) triple-lumen catheter with 2 compliant proximal and distal polyurethane balloons having a maximum diameter of 15 mm and 10 mm respectively. The 2 balloon lumens are connected to extension lines with stopcocks and are used to inflate and deflate the proximal and distal balloons. The third lumen is a guidewire lumen. The distance between the proximal and distal balloons is 2 cm. Two (2) radiopaque marker bands are located within the balloons at each end (30mm apart at the proximal balloon and 15mm apart at the distal balloon) to facilitate balloon placement prior to inflation. The catheter can accommodate a 0.014" diameter (or smaller) guidewire and is compatible with 6Fr (or larger) introducer sheath. The device is a single use, sterile device.