21 CFR 870.5925 — Tourniquet, Automatic Rotating

Cardiovascular (CV) · Part 870 Subpart F—Cardiovascular Therapeutic Devices · § 870.5925

Identification

An automatic rotating tourniquet is a device that prevents blood flow in one limb at a time, which temporarily reduces the total blood volume, thereby reducing the normal workload of the heart.

Classification Rationale

Class II (performance standards).

Product Codes

Product CodeDevice NameClassDevicesAttributes
DRPTourniquet, Automatic Rotating203rd Party
Innolitics

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