S3086 Arterial, S3087 Venous Neonatal Hemodialysis
FDA 510(k) K873455 · Dravon Medical, Inc.
510(k) numberK873455
Submission
- Device name
- S3086 Arterial, S3087 Venous Neonatal Hemodialysis
- Applicant
- Dravon Medical, Inc.
Clackamas, OR, US - Received
- August 28, 1987
- Decision date
- September 14, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- FJK – Set, Tubing, Blood, With And Without Anti-Regurgitation Valve
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5820
- Specialty
- Gastroenterology, Urology
- Life-sustaining
- Yes
Other 510(k)s with product code FJK
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K252423 | NovaLine Tubing Set for Hemodialysis (BL 124)FJK · Traditional | Bain Medical Equipment (Guangzhou) Co., Ltd. | 05/15/2026SE |
| K251341 | VITAL Tubing Sets for HemodialysisFJK · Traditional | Vital Healthcare Sdn. Bhd. | 01/16/2026SE |
| K251442 | TIANYI Extracorporeal Blood Tubing Set (TY-NDEO-A1)FJK · Traditional | Ningbo Tianyi Medical Appliance Co., Ltd. | 10/02/2025SE |
| K243607 | Moda-flx Hemodialysis System Cartridge (102121-001 )FJK · Special | Diality, Inc. | 12/20/2024SE |
| K213992 | CombiSet Hemodialysis Blood Tubing SetFJK · Traditional | Fresenius Medical Care Renal Therapies Group, LLC | 05/31/2023SE |
| K210782 | Tablo CartridgeFJK · Traditional | Outset Medical, Inc. | 11/26/2021SE |
| K202796 | SANSIN Tubing Sets for HemodialysisFJK · Traditional | Jiangxi Sanxin Medtec Co., Ltd. | 09/06/2021SE |
| K201866 | NovaLine Tubing Sets for HemodialysisFJK · Traditional | Bain Medical Equipment (Guangzhou) Co., Ltd. | 03/10/2021SE |
| K171952 | Dimesol Tubing Sets for HemodialysisFJK · Traditional | Dimesol, Inc. | 03/30/2018SE |
| K161582 | DORA Tubing Sets for HemodialysisFJK · Traditional | Bain Medical Equipment (Guangzhou) Co., Ltd. | 06/16/2017SE |
More from Bain Medical Equipment (Guangzhou) Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K860770 | AM-100 I/A AmpacHQC · Traditional | 04/21/1986SE |
| K832739 | Stediflo Infusion SetLDR · Traditional | 12/22/1983SE |
| K831842 | Dravon T ClampKDC · Traditional | 09/26/1983SE |
| K812772 | Peritoneal Dialysis Cycler Set (8UNIT)KDJ · Traditional | 10/19/1981SE |
| K812771 | Peritoneal Dialysis DrainageKDJ · Traditional | 10/19/1981SE |
| K811851 | S-610 Shunt Adaptor SetKNR · Traditional | 08/31/1981SE |
| K800435 | Hemostatic/Tube Occluding ForcepsGEN · Traditional | 03/12/1980SE |
| K782058 | Catheter, Beta-Cap-PeritonealFJS · Traditional | 02/27/1979SE |
| K782057 | Catheter, Radiopaque TenckhoffFJS · Traditional | 02/27/1979SE |
| K781755 | Dap-PakKDJ · Traditional | 02/15/1979SE |
Questions and answers
When was S3086 Arterial, S3087 Venous Neonatal Hemodialysis cleared by the FDA?
S3086 Arterial, S3087 Venous Neonatal Hemodialysis (K873455) received a 510(k) decision of Substantially Equivalent on September 14, 1987, 17 days after the submission was received.
What is the product code of K873455?
The FDA product code is FJK – Set, Tubing, Blood, With And Without Anti-Regurgitation Valve, a Class II (moderate risk) device regulated under 21 CFR 876.5820.