[Title 21 CFR 870.1250] [Code of Federal Regulations (annual edition) - April 1, 1996 Edition] [Title 21 - FOOD AND DRUGS] [Chapter I - FOOD AND DRUG ADMINISTRATION,] [Part 870 - CARDIOVASCULAR DEVICES] [Subpart B - Cardiovascular Diagnostic Devices] [Sec. 870.1250 - Percutaneous catheter.] [From the U.S. Government Publishing Office]21 FOOD AND DRUGS 8 1996-04-01 1996-04-01 false Percutaneous catheter. 870.1250 Sec. 870.1250 FOOD AND DRUGS FOOD AND DRUG ADMINISTRATION, CARDIOVASCULAR DEVICES Cardiovascular Diagnostic Devices Sec. 870.1250 Percutaneous catheter. (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).