StacksVerified U.S. regulatory reference

21 CFR §870.1280

Verified against eCFR.gov as of June 20, 2026View official text on eCFR.gov ↗
  1. (a)Identification. A steerable catheter is a catheter used for diagnostic and monitoring purposes whose movements are directed by a steering control unit.
  2. (b)Classification. Class II (performance standards).