Code of Federal Regulations · Section

§ 870.4240 — Cardiopulmonary Bypass Heat Exchanger

21 C.F.R. § 870.4240

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(a) Identification. A cardiopulmonary bypass heat exchanger is a device, consisting of a heat exchange system used in extracorporeal circulation to warm or cool the blood or perfusion fluid flowing through the device.

(b) Classification. Class II (performance standards).

21 C.F.R. § 870.4230 21 C.F.R. § 870.4250

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