Pharma-Plast Connecting Tube Type Suct-
FDA 510(k) K843470 · Zimmar Consulting , Ltd.
510(k) numberK843470
Submission
- Device name
- Pharma-Plast Connecting Tube Type Suct-
- Applicant
- Zimmar Consulting , Ltd.
Mchenry, IL, US - Received
- September 6, 1984
- Decision date
- November 16, 1984
- 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 |
|---|---|---|
| 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 |
| K843466 | Pharma-Plast Oxygen CatheterBZB · Traditional | 11/19/1984SE |
| 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 Connecting Tube Type Suct- cleared by the FDA?
Pharma-Plast Connecting Tube Type Suct- (K843470) received a 510(k) decision of Substantially Equivalent on November 16, 1984, 71 days after the submission was received.
What is the product code of K843470?
The FDA product code is BYY – Tube, Aspirating, Flexible, Connecting, a Class II (moderate risk) device regulated under 21 CFR 880.6740.