21 C.F.R. § 870.1290
Steerable catheter control system.
Cite as 21 C.F.R. § 870.1290 (2026)
(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).