BTQ · Airway, Nasopharyngeal
Anesthesiology · 21 CFR 868.5100 · Class 1
Overview
| Product Code | BTQ |
|---|---|
| Device Name | Airway, Nasopharyngeal |
| Regulation | 21 CFR 868.5100 |
| Device Class | Class 1 |
| Review Panel | Anesthesiology |
Identification
A nasopharyngeal airway is a device used to aid breathing by means of a tube inserted into a patient's pharynx through the nose to provide a patent airway.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 868.9.
Recent Cleared Devices (19 of 19)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K940320 | AD-TECH'S RAAB INFANT NASOPHARYNGEAL PRONGS | Ad-Tech Medical Instrument Corp | Sep 19, 1995 | SESE |
| K921353 | NASOPHARYNGEAL AIRWAY | Coast Medical Corp. | Jun 11, 1992 | SESE |
| K911784 | NORTEC ROBERTAZZI NASOPHARYNGEAL AIRWAY | North American Sterilization & Packaging Co. | Sep 23, 1991 | SESE |
| K903618 | ROBERTAZZI NASOPHARYNGEAL AIRWAY | Eastmed Enterprises, Inc. | Jan 8, 1991 | SESE |
| K900456 | POLAMEDCO NASOPAHARYNGEAL AIRWAY | Polamedco, Inc. | Apr 19, 1990 | SESE |
| K901279 | CHATHAM INDUSTRIES NASOPHARYNGEAL AIRWAY | Chatham Industries | Mar 28, 1990 | SESE |
| K883668 | SUNDERLAND NASAL TUBE | Exmoor Plastics , Ltd. | Nov 21, 1988 | SESE |
| K873949 | RORERTAZZI NASOPHARYNGEAL AIRWAY | Penn Medical Devices, Inc. | Oct 20, 1987 | SESE |
| K871673 | NASOPHARYNGEAL AIRWAY | Harding Industries, Inc. | Jun 15, 1987 | SESE |
| K853162 | STERILE NASOPHARYNGEAL AIRWAY | Inmed Corp. | Aug 6, 1985 | SESE |
| K850644 | NASOPHARYNGEAL AIRWAY-ROBERTAZZI | Dryden Corp. | Mar 21, 1985 | SESE |
| K843524 | LINDER NASOPHARYNGEAL AIRWAY | Polamedco, Inc. | Oct 4, 1984 | SESE |
| K841093 | NASOPHARYNGEAL AIRWAYS | Inmed Corp. | Mar 23, 1984 | SESE |
| K834078 | SILICONE RUGGER DISPOSABLE YOKE-CPAP | Vesta, Inc. | Dec 27, 1983 | SESE |
| K831476 | NASOPHARYNGEAL AIRWAY-ROBERTAZZI STYLE | Fls Medical Products, Inc. | Jun 10, 1983 | SESE |
| K830983 | AIRWAYS & NASOPHARYNGEAL TYPE | Medovations, Inc. | May 9, 1983 | SESE |
| K810960 | NASOPHARYNGEAL AIRWAY | Vesta, Inc. | Apr 23, 1981 | SESE |
| K792018 | SILICONE RUBBER-BI NASOPHARYNGEAL AIR | Vesta, Inc. | Nov 13, 1979 | SESE |
| K760125 | AIRWAY, ARGYLE NASOPHARYNGEAL | Sherwood Medical Industries | Jul 19, 1976 | SESE |
Top Applicants
- Vesta, Inc. — 3 clearances
- Polamedco, Inc. — 2 clearances
- Inmed Corp. — 2 clearances
- Sherwood Medical Industries — 1 clearance
- Penn Medical Devices, Inc. — 1 clearance
