Kawasumi A.V. Fistula Set
FDA 510(k) K873421 · Kawasumi Laboratories Co., Ltd.
510(k) numberK873421
Submission
- Device name
- Kawasumi A.V. Fistula Set
- Applicant
- Kawasumi Laboratories Co., Ltd.
Canoga Park, CA, US - Received
- August 25, 1987
- Decision date
- October 9, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- FKQ – System, Dialysate Delivery, Central Multiple Patient
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5820
- Specialty
- Gastroenterology, Urology
- Life-sustaining
- Yes
Other 510(k)s with product code FKQ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K052764 | Diacap Ultra Dialysis Fluid FilterFKQ · Traditional | B. Braun Medizintechnologie GmbH | 06/09/2006SE |
| K893612 | Two Tank Dissolution ModuleFKQ · Traditional | National Medical Care, Medical Products Div., Inc. | 07/24/1989SE |
| K874084 | Multiple Artificial Kidney Systems (Maks) #IdmFKQ · Traditional | National Medical Care, Medical Products Div., Inc. | 04/27/1988SE |
| K870889 | Acid Fuchsin SolutionsFKQ · Traditional | D.R.G. Scientific Industries | 07/08/1987SE |
| K861730 | Actril for Kidney Machine DisinfectantFKQ · Traditional | Renal Systems, Inc. | 06/09/1987SE |
| K864635 | Four Tank Dissolution ModuleFKQ · Traditional | National Medical Care, Medical Products Div., Inc. | 01/13/1987SE |
| K862304 | Drake Willock Central Dialysate Delivery SystemFKQ · Traditional | Cd Medical, Inc. | 09/09/1986SE |
| K861472 | Maks Central Delivery Systems Models 11-425/11-445FKQ · Traditional | National Medical Care, Medical Products Div., Inc. | 07/10/1986SE |
| K852359 | Amuchina/Dialyzer DisinfectantFKQ · Traditional | Amuchina Intl., Inc. | 05/13/1986SE |
| K860336 | Hemodialysis Concentrates and Related ProductsFKQ · Traditional | Breem Laboratories | 03/04/1986SE |
More from Breem Laboratories
| 510(k) | Device | Decision |
|---|---|---|
| K190485 | Kawasumi Multiple Sample Adapter with Pre-Attached Holder (MBCH)JKA · Traditional | 07/08/2019SE |
| K190233 | K-Shield Advantage Port Access Infusion Set (PAIS)FPA · Special | 05/02/2019SE |
| K172957 | Kawasumi Laboratories Blood Drawing Kit (BDK) SystemKSB · Traditional | 09/28/2018SE |
| K123344 | K-Shield Advantage Port Access Infusion Set (Pais)FPA · Traditional | 03/07/2013SE |
| K100720 | K-Shield Port Access Infusion Set with High Pressure TubingFPA · Traditional | 11/18/2010SE |
| K102994 | K-Shield Arterial Venous Fistula Set with Antineedle Stick ProtectorFMI · Special | 11/03/2010SE |
| K073257 | Kawasumi Laboratories Large Wing Sets with Antineedle Stick ProtectorFMI · Traditional | 01/25/2008SE |
| K061197 | Kawasumi Laboratories Empty Solution ContainerKPE · Traditional | 06/30/2006SE |
| K060580 | K-Shield Port Access Infusion SetFPA · Traditional | 06/06/2006SE |
| K023917 | Winged Needle Sets with an Antineedle Stick ProtectorFPA · Traditional | 02/26/2003SE |
Questions and answers
When was Kawasumi A.V. Fistula Set cleared by the FDA?
Kawasumi A.V. Fistula Set (K873421) received a 510(k) decision of Substantially Equivalent on October 9, 1987, 45 days after the submission was received.
What is the product code of K873421?
The FDA product code is FKQ – System, Dialysate Delivery, Central Multiple Patient, a Class II (moderate risk) device regulated under 21 CFR 876.5820.