Pharma-Plast Oxygen Catheter
FDA 510(k) K843466 · Zimmar Consulting , Ltd.
510(k) numberK843466
Submission
- Device name
- Pharma-Plast Oxygen Catheter
- Applicant
- Zimmar Consulting , Ltd.
Mchenry, IL, US - Received
- September 6, 1984
- Decision date
- November 19, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- BZB – Catheter, Nasal, Oxygen
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 868.5350
- Specialty
- Anesthesiology
Other 510(k)s with product code BZB
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K896731 | Oxygen CathetersBZB · Traditional | Unoplast A/S | 03/30/1990SE |
| K833351 | Demand Oxygen ControllerBZB · Traditional | Healthdyne, Inc. | 03/19/1984SE |
| K830984 | Oxygen CathetersBZB · Traditional | Medovations, Inc. | 05/18/1983SE |
| K820370 | Nasal Oxygen CatheterBZB · Traditional | American Pharmaseal Div. Ahsc | 04/16/1982SE |
| K800506 | Oxygen CatheterBZB · Traditional | Medi-Craft , Ltd. | 03/25/1980SE |
| K791273 | Conphar Oxygen Catheter-SterileBZB · Traditional | Conphar, Inc. | 07/24/1979SE |
| K790057 | Catheter, OxygenBZB · Traditional | Medline Industries, Inc. | 02/05/1979SE |
More from Medline Industries, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K860322 | Cliniset Infusion SetFPA · Traditional | 04/07/1986SE |
| K843478 | Pharma-Plast Uridrop-UridomeKNX · Traditional | 12/05/1984SE |
| K843477 | Pharma-Plast Rectal TipFCF · Traditional | 12/05/1984SE |
| K843468 | Pharma-Plast Suction Set Type YankauerGEA · Traditional | 11/23/1984SE |
| K843469 | Pharma-Plast Suction Tip, Type Orthopae-JOL · Traditional | 11/19/1984SE |
| K843467 | Pharma-Plast Nasal Oxygen CannulaCAT · Traditional | 11/19/1984SE |
| K843470 | Pharma-Plast Connecting Tube Type Suct-BYY · Traditional | 11/16/1984SE |
| K843475 | Pharma-Plast Single Use OvershoesFXP · Traditional | 10/31/1984SE |
| K843473 | Pharma-Plast Insulin SyringeFMF · Traditional | 10/31/1984SE |
| K843472 | Pharma-Plast Syringe with NeedleFMF · Traditional | 10/31/1984SE |
Questions and answers
When was Pharma-Plast Oxygen Catheter cleared by the FDA?
Pharma-Plast Oxygen Catheter (K843466) received a 510(k) decision of Substantially Equivalent on November 19, 1984, 74 days after the submission was received.
What is the product code of K843466?
The FDA product code is BZB – Catheter, Nasal, Oxygen, a Class I (low risk) device regulated under 21 CFR 868.5350.