Gambro Peritoneal Dialysis Fluid Lines
FDA 510(k) K811294 · Gambro, Inc.
510(k) numberK811294
Submission
- Device name
- Gambro Peritoneal Dialysis Fluid Lines
- Applicant
- Gambro, Inc.
Mchenry, IL, US - Received
- May 11, 1981
- Decision date
- June 12, 1981
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KDJ – Set, Administration, For Peritoneal Dialysis, Disposable
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5630
- Specialty
- Gastroenterology, Urology
- Life-sustaining
- Yes
Other 510(k)s with product code KDJ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K250404 | staysafe® catheter extension set with Safe- Lock, 12 inch; staysafe® catheter…KDJ · Traditional | Fresenius Medical Care Renal Therapies Group, LLC | 04/03/2025SE |
| K231849 | MiniCap Extended Life PD Transfer Set with Twist Clamp - Code 5C4482A; MiniCap Extended…KDJ · Traditional | Baxter Healthcare | 03/12/2024SE |
| K214016 | 15L Cycler Drainage BagKDJ · Traditional | Baxter Healthcare Corporation | 03/18/2022SE |
| K192705 | MiniCap Extended Life PD Transfer SetsKDJ · Special | Baxter Healthcare | 10/25/2019SE |
| K173593 | staysafe catheter extension set with Safe-Lock, 12 inch, staysafe catheter extension…KDJ · Traditional | Fresenius Medical Care Renal Therapies Group, LLC | 05/21/2018SE |
| K173651 | Multiple Tubing Segment Set with stay safe PIN Connectors, stay safe Drain SetKDJ · Traditional | Fresenius Medical Care Renal Therapies Group, LLC | 02/14/2018SE |
| K173363 | Cycler Drain Bag SetKDJ · Traditional | Fresenius Medical Care Renal Therapies Group, LLC | 01/24/2018SE |
| K151620 | Firefly Peritoneal Dialysis Connector Disinfection SystemKDJ · Traditional | Puracath Medical, Inc. | 01/20/2016SE |
| K152675 | Extended Life Capd Transfer Set, Peritoneal Dialysis Titanium Catheter Adapter and…KDJ · Traditional | Baxter Healthcare | 10/29/2015SE |
| K152129 | FlexiCap Disconnect Cap with Povidone-Iodine Solution, MiniCap with Povidone-Iodine…KDJ · Traditional | Baxter Healthcare Corporation | 10/29/2015SE |
More from Baxter Healthcare Corporation
| 510(k) | Device | Decision |
|---|---|---|
| K083158 | Exalis, Software Version 1.15KDI · Traditional | 06/05/2009SE |
| K072093 | Prismaflex System, Version 3.20KDI · Traditional | 02/01/2008SE |
| K070643 | Phoenix Hemodialysis Delivery System, Version 3.35KDI · Traditional | 11/02/2007SE |
| K032431 | Prisma M60/M100 SetsKDI · Special | 09/15/2003SE |
| K896758 | Gambro Bicarbonate Monitor BCM 10-3FKP · Traditional | 09/28/1990SE |
| K896757 | Gambro AK-10 Dialysis System for High FlowsFKP · Traditional | 08/30/1990SE |
| K902481 | Gambro Alwall GFS Plus 11, 16 & 20 Hollow FiberFJI · Traditional | 07/27/1990SE |
| K900918 | Gambro Lundia IC-6H Parallel Plate DialyzerKDI · Traditional | 07/16/1990SE |
| K892523 | Gambro Alwall GFS 11,12,PLUS 12 Hollow Fiber DialyFJI · Traditional | 05/11/1989SE |
| K890112 | Engstrom Eliza + CO2 AnalyzerCCK · Traditional | 03/15/1989SE |
Questions and answers
When was Gambro Peritoneal Dialysis Fluid Lines cleared by the FDA?
Gambro Peritoneal Dialysis Fluid Lines (K811294) received a 510(k) decision of Substantially Equivalent on June 12, 1981, 32 days after the submission was received.
What is the product code of K811294?
The FDA product code is KDJ – Set, Administration, For Peritoneal Dialysis, Disposable, a Class II (moderate risk) device regulated under 21 CFR 876.5630.