Nasopharyngeal Airway
FDA 510(k) K921353 · Coast Medical Corp.
510(k) numberK921353
Submission
- Device name
- Nasopharyngeal Airway
- Applicant
- Coast Medical Corp.
Orange, CA, US - Received
- March 19, 1992
- Decision date
- June 11, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- BTQ – Airway, Nasopharyngeal
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 868.5100
- Specialty
- Anesthesiology
Other 510(k)s with product code BTQ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K940320 | Ad-Tech's Raab Infant Nasopharyngeal ProngsBTQ · Traditional | Ad-Tech Medical Instrument Corp | 09/19/1995SE |
| K911784 | Nortec Robertazzi Nasopharyngeal AirwayBTQ · Traditional | North American Sterilization & Packaging Co. | 09/23/1991SE |
| K903618 | Robertazzi Nasopharyngeal AirwayBTQ · Traditional | Eastmed Enterprises, Inc. | 01/08/1991SE |
| K900456 | Polamedco Nasopaharyngeal AirwayBTQ · Traditional | Polamedco, Inc. | 04/19/1990SE |
| K901279 | Chatham Industries Nasopharyngeal AirwayBTQ · Traditional | Chatham Industries | 03/28/1990SE |
| K883668 | Sunderland Nasal TubeBTQ · Traditional | Exmoor Plastics , Ltd. | 11/21/1988SE |
| K873949 | Rorertazzi Nasopharyngeal AirwayBTQ · Traditional | Penn Medical Devices, Inc. | 10/20/1987SE |
| K871673 | Nasopharyngeal AirwayBTQ · Traditional | Harding Industries, Inc. | 06/15/1987SE |
| K853162 | Sterile Nasopharyngeal AirwayBTQ · Traditional | Inmed Corp. | 08/06/1985SE |
| K850644 | Nasopharyngeal Airway-RobertazziBTQ · Traditional | Dryden Corp. | 03/21/1985SE |
More from Dryden Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K952243 | Extension Set/I.V. SetFPK · Traditional | 07/26/1995SE |
| K930929 | Esophageal StethoscopeBZT · Traditional | 03/17/1995SE |
| K944729 | Stylet Sheath with Locking Cap and Reusable Battery Operated Light SourceBSR · Traditional | 12/21/1994SE |
| K943270 | Surface Temperature ProbesFLL · Traditional | 12/05/1994SE |
| K943495 | Disposable Esophageal StethoscopeBZT · Traditional | 09/08/1994SE |
| K943110 | Gas Sampling InterfacesBYX · Traditional | 08/19/1994SE |
| K930930 | Coast Medical, Inc. Rectal ProbeFLL · Traditional | 02/25/1994SE |
| K925781 | Disposable Cuffed Endotracheal TubeBTR · Traditional | 04/19/1993SE |
| K925855 | Disposable Uncuffed Endotracheal TubeBTR · Traditional | 02/18/1993SE |
| K921077 | Disposable Intubation KitsBTR · Traditional | 08/25/1992SE |
Questions and answers
When was Nasopharyngeal Airway cleared by the FDA?
Nasopharyngeal Airway (K921353) received a 510(k) decision of Substantially Equivalent on June 11, 1992, 84 days after the submission was received.
What is the product code of K921353?
The FDA product code is BTQ – Airway, Nasopharyngeal, a Class I (low risk) device regulated under 21 CFR 868.5100.