Code of Federal Regulations · Section
§ 870.1240 — Flow-directed Catheter
21 C.F.R. § 870.1240
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(a) Identification. A flow-directed catheter is a device that incorporates a gas-filled balloon to help direct the catheter to the desired position.
(b) Classification. Class II (performance standards).
Authorizing Statute
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Adulterated drugs and devices21 U.S.C. § 351