21 CFR § 870.1250 Cardiovascular Devices

§ 870.1250 Percutaneous catheter.

Current through Sep 8, 2026 · Read all of Part 870

⚠ 3 pending changes to Part 870

(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).

← § 870.1240 Flow-directed catheter.§ 870.1251 Temporary catheter for embolic protection during transcatheter intracardiac procedures. →