21 C.F.R. § 870.1250
Percutaneous catheter.
Cite as 21 C.F.R. § 870.1250 (2026)
(a)
Identification.
A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.
(b)
Classification.
Class II (performance standards).