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.
If 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.Therefore, they do not have a classification regulation in the CFR. In this case, the product classification database will only cite the device type name and product code.If it is unclear whether the unclassified device requires a PMA, use the three letter product code to search the PMA database and the Premarket Notification 510(k) database.n this case, the product classification database will only cite the device type name and product code. If it is unclear whether the unclassified device requires a PMA, use the three letter product code to search the PMA database and the Premarket Notification 510(k) database.