21 CFR § 870.5150 - Embolectomy catheter.

§ 870.5150 Embolectomy catheter.

(a)Identification. An embolectomy catheter is a balloon-tipped catheter that is used to remove thromboemboli, i.e., blood clots which have migrated in blood vessels from one site in the vascular tree to another.

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