Crit-Line IV System
FDA 510(k) K141997 · Fresenius Medical Care
510(k) numberK141997
Submission
- Device name
- Crit-Line IV System
- Applicant
- Fresenius Medical Care
Waltham, MA, US - Received
- July 23, 2014
- Decision date
- April 1, 2015
- 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
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| 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 |
| K141281 | Crit-Line Clip (Clic) Blood ChamberKOC · Traditional | Fresenius Medical Care Renal Therapies Group, LLC | 08/14/2014SE |
| K121599 | Crit-Line Clip (Clic)KOC · Traditional | Fresenius Medical Care-North America | 11/09/2012SE |
More from Fresenius Medical Care-North America
| 510(k) | Device | Decision |
|---|---|---|
| K231534 | 5008X Hemodialysis SystemKDI · Traditional | 02/02/2024SE |
| K111639 | Fresenius 2008T Hemodialysis MachineKDI · Special | 10/21/2011SE |
| K030497 | Fresenius Naturalyte Granuflo Dry Acid Concentrate 10XX Series, 24XX Series, 30XX SeriesKPO · Traditional | 05/20/2003SE |
| K023162 | Fresenius Punctur-Guard Fistula Needle SetsFIE · Traditional | 03/20/2003SE |
| K022536 | \Resenius Access Flow Reserving Connectors, Fresenius Standalone Accces Flow Reserving…KOC · Traditional | 10/30/2002SE |
| K994267 | Fresenius 2008KKDI · Traditional | 03/16/2000SE |
Questions and answers
When was Crit-Line IV System cleared by the FDA?
Crit-Line IV System (K141997) received a 510(k) decision of Substantially Equivalent on April 1, 2015, 252 days after the submission was received.
What is the product code of K141997?
The FDA product code is KOC – Accessories, Blood Circuit, Hemodialysis, a Class II (moderate risk) device regulated under 21 CFR 876.5820.