Emodren Guide Needle for Drainage Tube & Emodren
FDA 510(k) K853296 · Parexel Intl. Corp.
510(k) numberK853296
Submission
- Device name
- Emodren Guide Needle for Drainage Tube & Emodren
- Applicant
- Parexel Intl. Corp.
Cambridge, MA, US - Received
- August 6, 1985
- Decision date
- August 15, 1985
- 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 |
| K843470 | Pharma-Plast Connecting Tube Type Suct-BYY · Traditional | Zimmar Consulting , Ltd. | 11/16/1984SE |
More from Zimmar Consulting , Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K900385 | Acta Metra/Acta Gnosis Firmware PackageDSI · Traditional | 07/09/1991SE |
| K904902 | Sma 26 TransducerITX · Traditional | 03/26/1991SE |
| K904901 | L11, L12 Linear and C11, C12 Convex Array TransducITX · Traditional | 03/26/1991SE |
| K884800 | Acta Genos ElectrocardiographDPS · Traditional | 06/22/1989SE |
| K862414 | Fuji CR Imaging PlateEAM · Traditional | 02/26/1987SE |
| K864519 | Philips Computed Radiography System (PCR)LLZ · Traditional | 02/13/1987SE |
| K862416 | Fti 100 Medical Thermal ImagerLMC · Traditional | 07/01/1986SE |
| K862415 | Type 633 Computed Radiography (CR) FilmIWZ · Traditional | 07/01/1986SE |
| K853295 | Emodren Exchangeable Plastic BellowsGCY · Traditional | 08/20/1985SE |
| K851322 | Personal C3 3-CHANNEL ElectrocardiographDPS · Traditional | 05/16/1985SE |
Questions and answers
When was Emodren Guide Needle for Drainage Tube & Emodren cleared by the FDA?
Emodren Guide Needle for Drainage Tube & Emodren (K853296) received a 510(k) decision of Substantially Equivalent on August 15, 1985, 9 days after the submission was received.
What is the product code of K853296?
The FDA product code is BYY – Tube, Aspirating, Flexible, Connecting, a Class II (moderate risk) device regulated under 21 CFR 880.6740.