StacksVerified U.S. regulatory reference

21 CFR §870.4390

Verified against eCFR.gov as of June 20, 2026View official text on eCFR.gov
  1. (a)Identification. A cardiopulmonary bypass pump tubing is polymeric tubing which is used in the blood pump head and which is cyclically compressed by the pump to cause the blood to flow through the cardiopulmonary bypass circuit.
  2. (b)Classification. Class II (performance standards).