Medisystems Dialysis Priming Sets
FDA 510(k) K971860 · Medisystems Corp.
510(k) numberK971860
Submission
- Device name
- Medisystems Dialysis Priming Sets
- Applicant
- Medisystems Corp.
Washington, DC, US - Received
- May 20, 1997
- Decision date
- August 18, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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
Other 510(k)s with product code KOC
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
|---|---|---|
| K062953 | Medisystems Arterial-Venous Fistula Needle Set with Securement DeviceFIE · Traditional | 02/12/2007SE |
| K010279 | Medisystems Luer Access Injection SiteFPA · Traditional | 05/29/2001SE |
| K002372 | Access Alert GaugeKOC · Traditional | 10/25/2000SE |
| K994306 | ReversoKOC · Traditional | 03/20/2000SE |
| K990803 | Medisystems Buttonhole Needle SetsFIE · Traditional | 01/06/2000SE |
| K983076 | Medisystems Transducer ProtectorFIB · Traditional | 11/25/1998SE |
| K963668 | Medisystems Peritoneal Dialysis SetsKDJ · Traditional | 08/15/1997SE |
| K970536 | Medisystems Tranducer ProtectorFIB · Traditional | 05/12/1997SE |
| K953823 | Arterial Venous Blood Tubing SetFJK · Traditional | 09/23/1996SE |
| K932074 | Medisystems Apheresis Needle with GuardFIE · Traditional | 02/18/1994SE |
Questions and answers
When was Medisystems Dialysis Priming Sets cleared by the FDA?
Medisystems Dialysis Priming Sets (K971860) received a 510(k) decision of Substantially Equivalent on August 18, 1997, 90 days after the submission was received.
What is the product code of K971860?
The FDA product code is KOC – Accessories, Blood Circuit, Hemodialysis, a Class II (moderate risk) device regulated under 21 CFR 876.5820.