Gambro Lundia Alpha Hemodialyzers
FDA 510(k) K915504 · C.G.H. Medical, Inc.
510(k) numberK915504
Submission
- Device name
- Gambro Lundia Alpha Hemodialyzers
- Applicant
- C.G.H. Medical, Inc.
Lakewood, CO, US - Received
- December 9, 1991
- Decision date
- March 6, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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 |
| 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 |
| K862840 | Gambro Lundia 10-1L, 1N, 1H, 3H, 4N, 4H, 5H, 6NFJG · Traditional | Gambro, Inc. | 09/29/1986SE |
| 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 |
|---|---|---|
| K941708 | Cobe Centrysystem CS500 DialyzerFJI · Traditional | 05/12/1995SE |
| K933818 | Gambro Polyflux II Hemodialyzerialyzer HemodiafilterKDI · Traditional | 01/25/1995SE |
| K925522 | Centrysystem 3 with Charts/Bp OptionKOC · Traditional | 09/30/1994SE |
| K920757 | Filtral HemodialyzersKDI · Traditional | 08/05/1994SE |
| K931720 | Lundia Alpha 700 HemodialyzerKDI · Traditional | 07/07/1994SE |
| K924437 | Hemospal Kit B22 / Multiflow 60 KitKDI · Traditional | 06/27/1994SE |
| K940601 | Gambro Bicart 720GKPO · Traditional | 03/22/1994SE |
| K915154 | Gambro Engstrom Y Filter Pkg. Alone W/ Var.ModelsCAN · Traditional | 05/27/1992SE |
| K914271 | Gambro Engstrom Y-Filter with Edith Flex (1500F)CAN · Traditional | 04/13/1992SE |
| K911603 | Hemospal Kit B22KDI · Traditional | 08/07/1991SE |
Questions and answers
When was Gambro Lundia Alpha Hemodialyzers cleared by the FDA?
Gambro Lundia Alpha Hemodialyzers (K915504) received a 510(k) decision of Substantially Equivalent on March 6, 1992, 88 days after the submission was received.
What is the product code of K915504?
The FDA product code is FJG – Dialyzer, Parallel Flow, a Class II (moderate risk) device regulated under 21 CFR 876.5820.