Multiple Artificial Kidney Systems (Maks) #Idm
FDA 510(k) K874084 · National Medical Care, Medical Products Div., Inc.
510(k) numberK874084
Submission
- Device name
- Multiple Artificial Kidney Systems (Maks) #Idm
- Applicant
- National Medical Care, Medical Products Div., Inc.
Rockleigh, NJ, US - Received
- October 7, 1987
- Decision date
- April 27, 1988
- 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 |
| K873421 | Kawasumi A.V. Fistula SetFKQ · Traditional | Kawasumi Laboratories Co., Ltd. | 10/09/1987SE |
| 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 |
|---|---|---|
| K962081 | Combilines Hemodialysis Blood Tubing SetFJK · Traditional | 11/01/1996SE |
| K941757 | Formalin Reuse CartLIF · Traditional | 01/22/1996SE |
| K952343 | Focua 90R, 90HR, 120R, 120HR, 160R, 160HR Hollow Fiber DialyzerFJI · Traditional | 12/22/1995SE |
| K930843 | Rapid Disconnect Y-Set, Cat. No. 48-7000KDJ · Traditional | 08/31/1994SE |
| K914790 | Hollow Fiber Dialyzer Focus 9OR/90H-R/120R/120H-RFJI · Traditional | 03/05/1993SE |
| K920797 | Hemodialysis Blood Tubing SetFJK · Traditional | 09/21/1992SE |
| K920697 | Dextrolyte II Peritoneal Dialysis 48-3029-7 ClampFJH · Traditional | 09/21/1992SE |
| K920693 | Dextrolyte II Peritoneal Dialysis 48-3028-9FJG · Traditional | 09/21/1992SE |
| K920586 | Dextrolyte II Peritoneal Dialysis Admin. SetKDJ · Traditional | 09/21/1992SE |
| K920029 | Dextrolyte II Capd Trnsfer SetKDJ · Traditional | 09/21/1992SE |
Questions and answers
When was Multiple Artificial Kidney Systems (Maks) #Idm cleared by the FDA?
Multiple Artificial Kidney Systems (Maks) #Idm (K874084) received a 510(k) decision of Substantially Equivalent on April 27, 1988, 203 days after the submission was received.
What is the product code of K874084?
The FDA product code is FKQ – System, Dialysate Delivery, Central Multiple Patient, a Class II (moderate risk) device regulated under 21 CFR 876.5820.