CFR > Title 21 - Food and Drugs > CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES > SUBCHAPTER H—MEDICAL DEVICES (parts 800 to 898) > PART 874—EAR, NOSE, AND THROAT DEVICES > SUBPART F—Therapeutic Devices (§874.5220 to §874.5840) > 874.5350—Suction antichoke device.

874.5350—Suction antichoke device.

(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.

Code of Federal Regulations

[51 FR 40389, Nov. 6, 1986, as amended at 64 FR 18329, Apr. 14, 1999; 65 FR 2316, Jan. 14, 2000]