Code of Federal Regulations · Section
§ 870.1250 — Percutaneous Catheter
21 C.F.R. § 870.1250
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(a) Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.
(b) Classification. Class II (performance standards).
Authorizing Statute
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Adulterated drugs and devices21 U.S.C. § 351