Gambro Lundia 10-1L, 1N, 1H, 3H, 4N, 4H, 5H, 6N
FDA 510(k) K862840 · Gambro, Inc.
510(k) numberK862840
Submission
- Device name
- Gambro Lundia 10-1L, 1N, 1H, 3H, 4N, 4H, 5H, 6N
- Applicant
- Gambro, Inc.
Lincolnshire, IL, US - Received
- July 29, 1986
- Decision date
- September 29, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- FJG – Dialyzer, Parallel Flow
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5820
- Specialty
- Gastroenterology, Urology
- Life-sustaining
- Yes
Other 510(k)s with product code FJG
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K933681 | Gambro Lundia Pro 100, 500, 600 DialyzersFJG · Traditional | Cobe Renal Care, Inc. | 09/07/1994SE |
| K933680 | Gambro Lundia Pro 200 DialyzerFJG · Traditional | Cobe Renal Care, Inc. | 08/26/1994SE |
| K920693 | Dextrolyte II Peritoneal Dialysis 48-3028-9FJG · Traditional | National Medical Care, Medical Products Div., Inc. | 09/21/1992SE |
| K915504 | Gambro Lundia Alpha HemodialyzersFJG · Traditional | C.G.H. Medical, Inc. | 03/06/1992SE |
| K901368 | Hemospal Kits A1, A2D, Ao, & A1DFJG · Traditional | Gambro-Hospal, Inc. | 08/02/1990SE |
| K902203 | Tenckhoff Peritoneal Dialysis KitFJG · Traditional | Akcess Medical Products, Inc. | 08/01/1990SESK |
| K853406 | Gambro Lundia Pro 3 & 5 DialyzerFJG · Traditional | Gambro, Inc. | 01/08/1986SE |
| K820694 | Cobe PPD 1.3L, #18-520-009FJG · Traditional | Cobe Laboratories, Inc. | 03/31/1982SE |
| K812336 | Cobe PPD 1.9FJG · Traditional | Cobe Laboratories, Inc. | 08/31/1981SE |
| K811440 | Exp 600 Parallel Plate DialyzerFJG · Traditional | Extracorporeal Medical Specialities, Inc. | 06/12/1981SE |
More from Extracorporeal Medical Specialities, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K083158 | Exalis, Software Version 1.15KDI · Traditional | 06/05/2009SE |
| K072093 | Prismaflex System, Version 3.20KDI · Traditional | 02/01/2008SE |
| K070643 | Phoenix Hemodialysis Delivery System, Version 3.35KDI · Traditional | 11/02/2007SE |
| K032431 | Prisma M60/M100 SetsKDI · Special | 09/15/2003SE |
| K896758 | Gambro Bicarbonate Monitor BCM 10-3FKP · Traditional | 09/28/1990SE |
| K896757 | Gambro AK-10 Dialysis System for High FlowsFKP · Traditional | 08/30/1990SE |
| K902481 | Gambro Alwall GFS Plus 11, 16 & 20 Hollow FiberFJI · Traditional | 07/27/1990SE |
| K900918 | Gambro Lundia IC-6H Parallel Plate DialyzerKDI · Traditional | 07/16/1990SE |
| K892523 | Gambro Alwall GFS 11,12,PLUS 12 Hollow Fiber DialyFJI · Traditional | 05/11/1989SE |
| K890112 | Engstrom Eliza + CO2 AnalyzerCCK · Traditional | 03/15/1989SE |
Questions and answers
When was Gambro Lundia 10-1L, 1N, 1H, 3H, 4N, 4H, 5H, 6N cleared by the FDA?
Gambro Lundia 10-1L, 1N, 1H, 3H, 4N, 4H, 5H, 6N (K862840) received a 510(k) decision of Substantially Equivalent on September 29, 1986, 62 days after the submission was received.
What is the product code of K862840?
The FDA product code is FJG – Dialyzer, Parallel Flow, a Class II (moderate risk) device regulated under 21 CFR 876.5820.