Van Dellen Aspirating Tubing
FDA 510(k) K873463 · Van Dellen, Ltd.
510(k) numberK873463
Submission
- Device name
- Van Dellen Aspirating Tubing
- Applicant
- Van Dellen, Ltd.
Tucson, AZ, US - Received
- August 28, 1987
- Decision date
- November 23, 1987
- 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 |
| K853296 | Emodren Guide Needle for Drainage Tube & EmodrenBYY · Traditional | Parexel Intl. Corp. | 08/15/1985SE |
| K843470 | Pharma-Plast Connecting Tube Type Suct-BYY · Traditional | Zimmar Consulting , Ltd. | 11/16/1984SE |
More from Zimmar Consulting , Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K873465 | Van Dellen Bacteria FilterFPK · Traditional | 01/20/1988SE |
| K873464 | Van Dellen CannulaJOL · Traditional | 11/23/1987SE |
| K873462 | Van Dellen AspiratorBTA · Traditional | 09/25/1987SE |
| K873164 | Van Dellen Healon CannulaHMX · Traditional | 09/04/1987SE |
| K873163 | Van Dellen Irrigating CystotomeHNY · Traditional | 09/04/1987SE |
| K873162 | Van Dellen Retrobulbar NeedleHMX · Traditional | 09/04/1987SE |
Questions and answers
When was Van Dellen Aspirating Tubing cleared by the FDA?
Van Dellen Aspirating Tubing (K873463) received a 510(k) decision of Substantially Equivalent on November 23, 1987, 87 days after the submission was received.
What is the product code of K873463?
The FDA product code is BYY – Tube, Aspirating, Flexible, Connecting, a Class II (moderate risk) device regulated under 21 CFR 880.6740.