21 CFR 874.5350
§ 874.5350 Suction antichoke device.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 874.5350, § 874.5350 Suction antichoke device, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/90255
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Full text
(a) Identification. A suction antichoke device is a device intended to be used in an emergency situation to remove, by the application of suction, foreign objects that obstruct a patient's airway to prevent asphyxiation to the patient.
(b) Classification. Class III.
(c) Date PMA or notice of completion of PDP is required. A PMA or a notice of completion of a PDP for a device is required to be filed with the Food and Drug Administration on or before July 13, 1999 for any suction antichoke device that was in commercial distribution before May 28, 1976, or that has, on or before July 13, 1999, been found to be substantially equivalent to a suction antichoke device that was in commercial distribution before May 28, 1976. Any other suction antichoke device shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.