21 C.F.R. § 870.1290 Steerable catheter control system.
Title 21 - Food and Drugs
(a) Identification. A steerable catheter control system is a device that is connected to the proximal end of a steerable guide wire that controls the motion of the steerable catheter. (b) Classification. Class II (performance standards).
Title 21: Food and Drugs
PART 870—CARDIOVASCULAR DEVICES
Subpart B—Cardiovascular Diagnostic Devices
§ 870.1290 Steerable catheter control system.