StacksVerified U.S. regulatory reference

21 CFR §870.1250

Verified against eCFR.gov as of June 20, 2026View official text on eCFR.gov ↗
  1. (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.
  2. (b)Classification. Class II (performance standards).