StacksVerified U.S. regulatory reference

21 CFR §870.1340

Verified against eCFR.gov as of June 20, 2026View official text on eCFR.gov ↗
  1. (a)Identification. A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.
  2. (b)Classification. Class II (performance standards).