Arteries (from Greek á¼ÏÏÎ·ÏÎ¯Î± (artÄria) , meaning windpipe, artery) are blood vessels that carry blood away from the heart.While most arteries carry oxygenated blood, there are two exceptions to this, the pulmonary and the umbilical arteries.ystemic arteries are the arteries (including the peripheral arteries), of the systemic circulation, which is the part of the cardiovascular system that carries oxygenated blood away from the heart, to the body arterioles, and then to the capillaries, where nutrients and gases are exchanged.
The Medical Devices Bureau of Health Canada recognizes four classes of medical devices based on the level of control necessary to assure the safety and effectiveness of the device. Class I devices present the lowest potential risk and do not require a licence.
The regulation governing premarket approval is located in Title 21 Code of Federal Regulations (CFR) Part 814, Premarket Approval. A class III device that fails to meet PMA requirements is considered to be adulterated under section 501(f) of the FD&C Act and cannot be marketed.[ back to top ].f the regulation in the CFR states that âNo effective date has been established of the requirement for premarket approval,â a Class III 510(k) should be submitted. Please note that PMA devices often involve new concepts and many are not of a type marketed prior to the Medical Device Amendments.