Tenckhoff Peritoneal Dialysis Kit
FDA 510(k) K902203 · Akcess Medical Products, Inc.
510(k) numberK902203
Submission
- Device name
- Tenckhoff Peritoneal Dialysis Kit
- Applicant
- Akcess Medical Products, Inc.
New Brunswick, NJ, US - Received
- May 16, 1990
- Decision date
- August 1, 1990
- Decision
- Unknown (SESK)
- 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 |
| 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 |
|---|---|---|
| K926374 | Silicone Catheter Repair KitsKOC · Traditional | 10/07/1994SESK |
| K925819 | AKCESS0CATH KitLFJ · Traditional | 08/02/1994SE |
| K925818 | Akcess-CathLFJ · Traditional | 04/05/1994SE |
| K930630 | Right Atrial CatheterLJS · Traditional | 02/07/1994SN |
| K931120 | Coaxial Acute CatheterLFJ · Traditional | 01/14/1994SE |
| K920634 | Splittable Sheath Introducer SetLFJ · Traditional | 01/14/1994SE |
| K914936 | Continuous Arteriovenous Hemofiltration Cath SetLFK · Traditional | 04/23/1992SESK |
| K920331 | Right Atrial Catheter KitsDQY · Traditional | 04/22/1992SESK |
| K914826 | Akcess-Cath KitLFJ · Traditional | 04/10/1992SESK |
| K915215 | Continuous Arteriovenous Hemofiltration Cath. KitsLFK · Traditional | 03/27/1992SESK |
Questions and answers
When was Tenckhoff Peritoneal Dialysis Kit cleared by the FDA?
Tenckhoff Peritoneal Dialysis Kit (K902203) received a 510(k) decision of Unknown on August 1, 1990, 77 days after the submission was received.
What is the product code of K902203?
The FDA product code is FJG – Dialyzer, Parallel Flow, a Class II (moderate risk) device regulated under 21 CFR 876.5820.