21 CFR 870.4310 — Gauge, Pressure, Coronary, Cardiopulmonary Bypass

Cardiovascular (CV) · Part 870 Subpart E—Cardiovascular Surgical Devices · § 870.4310

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.

Classification Rationale

Class II (performance standards).

Product Codes

Product CodeDevice NameClassDevicesAttributes
DXSGauge, Pressure, Coronary, Cardiopulmonary Bypass2133rd Party
Innolitics

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