Source: https://www.law.cornell.edu/cfr/text/21/870.4200
Timestamp: 2019-06-24 12:31:05
Document Index: 625570491

Matched Legal Cases: ['§ 870', 'art 870', '§ 870', '§ 870', 'art 807', '§ 870', 'art 807', '§ 870']

21 CFR § 870.4200 - Cardiopulmonary bypass accessory equipment. | CFR | US Law | LII / Legal Information Institute
Subchapter H. MEDICAL DEVICES
Part 870. CARDIOVASCULAR DEVICES
Subpart E. Cardiovascular Surgical Devices
Section 870.4200. Cardiopulmonary bypass accessory equipment.
21 CFR § 870.4200 - Cardiopulmonary bypass accessory equipment.
§ 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.
(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.