(191 days)
The intended use of this device is for occlusion of the internal carotid artery during endarterectorny.
The Pruitt Safety Occlusion Catheter is a single lumen balloon catheter. There is an external safety balloon designed to inflate when the intraluminal balloon reaches 17 psi. This reduces the possibility of balloon overinflation. All materials have been used by Ideas for Medicine, Inc. for many years to manufacture other Class II devices. All materials have been subject to Biocompatibility testing. Every lot is supplied sterile and nonpyrogenic.
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§ 870.4450 Vascular clamp.
(a)
Identification. A vascular clamp is a surgical instrument used to occlude a blood vessel temporarily.(b)
Classification. Class II (performance standards).