Plastic Tubing Connectors
FDA 510(k) K831920 · Polymer Technology Corp.
510(k) numberK831920
Submission
- Device name
- Plastic Tubing Connectors
- Applicant
- Polymer Technology Corp.
Mchenry, IL, US - Received
- June 14, 1983
- Decision date
- July 19, 1983
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- BYY – Tube, Aspirating, Flexible, Connecting
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.6740
- Specialty
- General Hospital
Other 510(k)s with product code BYY
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K960616 | Vitaflow Suction/Aspiration Tubing SetBYY · Traditional | Vital Concepts, Inc. | 05/06/1996SE |
| K960218 | Connecting TubingBYY · Traditional | Custom Pack Reliability | 03/28/1996SE |
| K955151 | Maxi-Flow Suction Tube/Top Gun Suction IrrigatorBYY · Traditional | Bio-Medical Devices, Inc. | 01/24/1996SE |
| K955149 | Maxi-Flow Suction Handle/The Reel Thing Tubing ReelBYY · Traditional | Bio-Medical Devices, Inc. | 01/24/1996SE |
| K955150 | Maxi-FlowBYY · Traditional | Bio-Medical Devices, Inc. | 01/23/1996SE |
| K922989 | Wiltek Irrigaiton/Aspiration Tube SetBYY · Traditional | Wiltek Medical, Inc. | 02/15/1994SE |
| K911586 | General Hospital Tubing Clamp (Non-Electric)BYY · Traditional | Megadyne Medical Products, Inc. | 07/02/1991SE |
| K901761 | Sterile Suction Tubing SetBYY · Traditional | Acacia Laboratories, Inc. | 05/07/1990SE |
| K873463 | Van Dellen Aspirating TubingBYY · Traditional | Van Dellen, Ltd. | 11/23/1987SE |
| K853296 | Emodren Guide Needle for Drainage Tube & EmodrenBYY · Traditional | Parexel Intl. Corp. | 08/15/1985SE |
More from Parexel Intl. Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K011945 | Rigid Gas Permeable Contact Lens SolutionHQD · Traditional | 09/12/2001SE |
| K003933 | Boston Equalens II (Oprifocon a) Contact Lens for OrthokeratolgyMUW · Traditional | 02/16/2001SE |
| K003932 | Boston Eo (Enflufocon B) Contact Lens for OrthokeratolgyHQD · Traditional | 02/16/2001SE |
| K002025 | Rigid Gas Permeable Contact LensHQD · Traditional | 10/31/2000SE |
| K001960 | Rigid Gas Permeable Contact LensHQD · Traditional | 08/28/2000SE |
| K000795 | Rigid Gas Permeable Contact LensHQD · Traditional | 05/26/2000SE |
| K980133 | Bausch & Lomb Wetting and Soaking SolutionLPN · Traditional | 03/11/1998SE |
| K974466 | Boston Advance CleanerMRC · Traditional | 02/19/1998SE |
| K973217 | Boston Liquid Enzymatic CleanerLPN · Traditional | 11/24/1997SE |
| K970698 | Boston Es Multivision (Enflufocon a) Contact LensHQD · Traditional | 05/06/1997SE |
Questions and answers
When was Plastic Tubing Connectors cleared by the FDA?
Plastic Tubing Connectors (K831920) received a 510(k) decision of Substantially Equivalent on July 19, 1983, 35 days after the submission was received.
What is the product code of K831920?
The FDA product code is BYY – Tube, Aspirating, Flexible, Connecting, a Class II (moderate risk) device regulated under 21 CFR 880.6740.