Exp 200 Parallel Plate Dialyzer
FDA 510(k) K811439 · Extracorporeal Medical Specialities, Inc.
510(k) numberK811439
Submission
- Device name
- Exp 200 Parallel Plate Dialyzer
- Applicant
- Extracorporeal Medical Specialities, Inc.
Mchenry, IL, US - Received
- May 22, 1981
- Decision date
- June 12, 1981
- 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 |
| 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 |
More from Cobe Laboratories, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K843955 | Extracorporeal Maxima Hollow Fiber OxygenatorDTZ · Traditional | 11/29/1984SE |
| K840532 | Hemoperfusion System TP-400FLD · Traditional | 05/30/1984SE |
| K840262 | Hancock Pericardial PatchDXZ · Traditional | 05/30/1984SE |
| K840146 | Exp* 700 Parallel Plate DialyzerKOC · Traditional | 02/04/1984SE |
| K840057 | Exp* 500 Parallel Plate DialyzerKOC · Traditional | 02/04/1984SE |
| K832547 | Ultrafiltration ControllerKDI · Traditional | 01/03/1984SE |
| K831423 | Therapeutic Exchange SystemLQQ · Traditional | 01/03/1984SE |
| K833477 | Intersept 40 Micron FilterDTM · Traditional | 12/27/1983SE |
| K833476 | Intersept 40 Micron Filter W/TubingDTM · Traditional | 12/27/1983SE |
| K831424 | Therapeutic Exchange Blood TUBING-TP-101FJK · Traditional | 10/14/1983SE |
Questions and answers
When was Exp 200 Parallel Plate Dialyzer cleared by the FDA?
Exp 200 Parallel Plate Dialyzer (K811439) received a 510(k) decision of Substantially Equivalent on June 12, 1981, 21 days after the submission was received.
What is the product code of K811439?
The FDA product code is FJG – Dialyzer, Parallel Flow, a Class II (moderate risk) device regulated under 21 CFR 876.5820.