Code of Federal Regulations · Section
§ 870.1280 — Steerable Catheter
21 C.F.R. § 870.1280
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(a) Identification. A steerable catheter is a catheter used for diagnostic and monitoring purposes whose movements are directed by a steering control unit.
(b) Classification. Class II (performance standards).
Authorizing Statute
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Adulterated drugs and devices21 U.S.C. § 351