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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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Help | More About 21CFR
[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2014]
[CITE: 21CFR870.4200]
See Related Information on Cardiopulmonary bypass accessory equipment. in CDRH databases



TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER H--MEDICAL DEVICES

PART 870 -- CARDIOVASCULAR DEVICES

Subpart E--Cardiovascular Surgical Devices

Sec. 870.4200 Cardiopulmonary bypass accessory equipment.

(a) Identification. Cardiopulmonary bypass accessory equipment is a device that has no contact with blood and that is used in the cardiopulmonary bypass circuit to support, adjoin, or connect components, or to aid in the setup of the extracorporeal line, e.g., an oxygenator mounting bracket or system-priming equipment.

(b) Classification. (1) Class I. The device is classified as class I if it does not involve an electrical connection to the patient. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to 870.9.

(2) Class II (special controls). The device is classified as class II if it involves an electrical connection to the patient. The special controls are as follows:

(i) The performance standard under part 898 of this chapter, and

(ii) The guidance document entitled "Guidance on the Performance Standard for Electrode Lead Wires and Patient Cables." The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to 870.9.

[65 FR 19319, Apr. 11, 2000]

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