Code of Federal Regulations · Section
§ 870.5150 — Embolectomy Catheter
21 C.F.R. § 870.5150
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(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).
Authorizing Statute
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Adulterated drugs and devices21 U.S.C. § 351