Gambro Lundia Pro 100, 500, 600 Dialyzers
FDA 510(k) K933681 · Cobe Renal Care, Inc.
510(k) numberK933681
Submission
- Device name
- Gambro Lundia Pro 100, 500, 600 Dialyzers
- Applicant
- Cobe Renal Care, Inc.
Lakewood, CO, US - Received
- July 29, 1993
- Decision date
- September 7, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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 |
|---|---|---|---|
| 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 |
| 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 |
|---|---|---|
| K955497 | Gambro FH 22H Fiber Hemofltr/Prisma FH 22H Blood Tubing/Hemofltr SetKDL · Traditional | 09/25/1997SE |
| K955592 | Cobe Centrysystem 14 Pes HemodialyzersKDI · Traditional | 04/30/1997SE |
| K955487 | Gambro Polyflux 14, 17, & 21 HemodialyzersKDI · Traditional | 04/18/1997SE |
| K946279 | Prisma CFM (Continuous Fluid Management System)KDI · Traditional | 02/10/1997SE |
| K954003 | Cobe Hemodynamic Recirculation MonitorMQS · Traditional | 02/06/1997SE |
| K960474 | Cobe Centrysystem 600 HG HemodialyzersKDI · Traditional | 08/14/1996SE |
| K944436 | Cobe Centrysystem CS 200 DialyzerFJI · Traditional | 01/29/1996SE |
| K951311 | Gambro HC 14R HemoconcentratorKDI · Traditional | 01/11/1996SE |
| K952342 | Gambro Lundia 94-700 & Sigma 800 HemodialyzersKDI · Traditional | 09/15/1995SE |
| K945747 | Gambro Lundia 94-600 DialyzerKDI · Traditional | 09/08/1995SE |
Questions and answers
When was Gambro Lundia Pro 100, 500, 600 Dialyzers cleared by the FDA?
Gambro Lundia Pro 100, 500, 600 Dialyzers (K933681) received a 510(k) decision of Substantially Equivalent on September 7, 1994, 405 days after the submission was received.
What is the product code of K933681?
The FDA product code is FJG – Dialyzer, Parallel Flow, a Class II (moderate risk) device regulated under 21 CFR 876.5820.