21 C.F.R. § 870.1280 Steerable catheter.
Title 21 - Food and Drugs
(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).
Title 21: Food and Drugs
PART 870—CARDIOVASCULAR DEVICES
Subpart B—Cardiovascular Diagnostic Devices
§ 870.1280 Steerable catheter.