Catheter, Nasal, Oxygen
The Catheter, Nasal, Oxygen is a flexible catheter inserted into a nostril and advanced into the nasopharynx to deliver supplemental oxygen directly to the upper airway for patients requiring low-to-moderate flow oxygen therapy. It is classified as FDA Class 1, the lowest risk category, subject to general controls only with no premarket submission required. The product code is BZB, regulated under 21 CFR 868.5350 in the Anesthesiology specialty.
Basic Information
- Product Code
- BZB
- Device Class
- FDA class 1
- Regulation Number
- 868.5350
- Medical Specialty
- Anesthesiology
- Review Panel
- AN
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 8 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K896731 | OXYGEN CATHETERS | Mar 30, 1990 | Substantially Equivalent | Unoplast A/S |
| K843466 | PHARMA-PLAST OXYGEN CATHETER | Nov 19, 1984 | Substantially Equivalent | Zimmar Consulting , Ltd. |
| K833351 | DEMAND OXYGEN CONTROLLER | Mar 19, 1984 | Substantially Equivalent | Healthdyne, Inc. |
| K830984 | OXYGEN CATHETERS | May 18, 1983 | Substantially Equivalent | Medovations, Inc. |
| K820370 | NASAL OXYGEN CATHETER | Apr 16, 1982 | Substantially Equivalent | American Pharmaseal Div. Ahsc |
| K800506 | OXYGEN CATHETER | Mar 25, 1980 | Substantially Equivalent | Medi-Craft , Ltd. |
| K791273 | CONPHAR OXYGEN CATHETER-STERILE | Jul 24, 1979 | Substantially Equivalent | Conphar, Inc. |
| K790057 | CATHETER, OXYGEN | Feb 05, 1979 | Substantially Equivalent | Medline Industries, Inc. |
FEI Numbers
This FDA classification entry is associated with 36 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 36 registration numbers. Click on an entry to view related FDA registrations.