Filtryzer Hollow Fiber Artif. Kidney
FDA 510(k) K831175 · Erika, Inc.
510(k) numberK831175
Submission
- Device name
- Filtryzer Hollow Fiber Artif. Kidney
- Applicant
- Erika, Inc.
Walker, MI, US - Received
- April 11, 1983
- Decision date
- June 22, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KOC – Accessories, Blood Circuit, Hemodialysis
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5820
- Specialty
- Gastroenterology, Urology
- Life-sustaining
- Yes
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|---|---|---|---|
| K242479 | BLOOD TUBING LINES FOR HEMODIALYSIS AL Series (Archloop) BLOOD TUBING LINES FOR…KOC · Traditional | Nikkiso Co., Ltd. | 05/15/2025SE |
| K242176 | BLOOD TUBING LINES FOR HEMODIALYSIS AL Series (Archloop) BLOOD TUBING LINES FOR…KOC · Traditional | Nikkiso Co., Ltd. | 05/15/2025SE |
| K231589 | Blood Tubing Lines for Hemodialysis AV06C-EKOC · Traditional | Nikkiso Co., Ltd. | 07/28/2023SE |
| K230514 | Blood Tubing Lines for Hemodialysis AL Series (Archloop), Blood Tubing Lines for…KOC · Traditional | Nikkiso Co., Ltd. | 06/16/2023SE |
| K201207 | CombiSet SMARTECH Hemodialysis Blood Tubing Set with attached Priming Set and Integrated…KOC · Traditional | Fresenius Medical Care Renal Therapies Group, LLC | 09/18/2020SE |
| K172238 | CAREline Airless Hemodialysis Blood Tubing SetsKOC · Traditional | Fresenius Medical Care Renal Therapies Group, LLC | 12/14/2017SE |
| K160749 | CRIT-LINE III Blood Chamber IIKOC · Special | Fresenius Medical Care Renal Therapies Group, LLC | 04/15/2016SE |
| K152953 | Crit-Line Clip (Clic) Blood ChamberKOC · Special | Fresenius Medical Care North America | 11/05/2015SE |
| K141997 | Crit-Line IV SystemKOC · Traditional | Fresenius Medical Care | 04/01/2015SE |
| K141281 | Crit-Line Clip (Clic) Blood ChamberKOC · Traditional | Fresenius Medical Care Renal Therapies Group, LLC | 08/14/2014SE |
More from Fresenius Medical Care Renal Therapies Group, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K853134 | National Med Care Infusion Pump Adm Set #95-0001-8FRN · Traditional | 11/06/1985SE |
| K852310 | Naturalyte Bicarbonate Concentrate-Dry PackFKQ · Traditional | 07/26/1985SE |
| K852309 | Erika Art Li, 3-9621-8, 22-6, 23-4 & Ven 9714-1FJK · Traditional | 07/26/1985SE |
| K850866 | Toray Industries Filtryzer Hollow Fiber Kidney B1LKDI · Traditional | 04/03/1985SE |
| K850865 | Toray Industries Filtryzer Hollow Fiber Kidney B1-FJI · Traditional | 04/03/1985SE |
| K850655 | Toray Ind. Filtryzer Hollow Fiber Artif. Kidney B2FJI · Traditional | 03/07/1985SE |
| K850654 | Toray Indus. Filtryzer Hollow Fiber Artificial KidFJI · Traditional | 03/07/1985SE |
| K842436 | Erika Negative Press. Arterial BloodKOC · Traditional | 07/13/1984SE |
| K831176 | Filtryzer Hollow Fiber Artif. KidneyKOC · Traditional | 06/22/1984SE |
| K831174 | Filtryzer Hollow Fiber Artificial Kid-KOC · Traditional | 06/22/1984SE |
Questions and answers
When was Filtryzer Hollow Fiber Artif. Kidney cleared by the FDA?
Filtryzer Hollow Fiber Artif. Kidney (K831175) received a 510(k) decision of Substantially Equivalent on June 22, 1984, 438 days after the submission was received.
What is the product code of K831175?
The FDA product code is KOC – Accessories, Blood Circuit, Hemodialysis, a Class II (moderate risk) device regulated under 21 CFR 876.5820.