21 CFR § 870.4390 - Cardiopulmonary bypass pump tubing.

---
identifier: "/us/cfr/t21/s870.4390"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 870.4390 - Cardiopulmonary bypass pump tubing."
title_number: 21
title_name: "Food and Drugs"
section_number: "870.4390"
section_name: "Cardiopulmonary bypass pump tubing."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "H"
subchapter_name: "MEDICAL DEVICES"
part_number: "870"
part_name: "CARDIOVASCULAR DEVICES"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 351, 360, 360c, 360e, 360j, 360 371."
regulatory_source: "45 FR 7907, Feb. 5, 1980, unless otherwise noted."
cfr_part: "870"
---


# 870.4390 Cardiopulmonary bypass pump tubing.

(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.

(b) *Classification.* Class II (performance standards).