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21 C.F.R. § 870.4310 – Cardiopulmonary bypass coronary pressure gauge. | Midpage
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Code of Federal Regulations
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Subchapter H
Part 870
Subpart E
§ 870.4310
21 C.F.R. § 870.4310
Cardiopulmonary bypass coronary pressure gauge.
(a)
Identification.
A cardiopulmonary bypass coronary pressure gauge is a device used in cardiopulmonary bypass surgery to measure the pressure of the blood perfusing the coronary arteries.
(b)
Classification.
Class II (performance standards).