Crit-Line Clip (Clic) Blood Chamber
FDA 510(k) K152953 · Fresenius Medical Care North America
510(k) numberK152953
Submission
- Device name
- Crit-Line Clip (Clic) Blood Chamber
- Applicant
- Fresenius Medical Care North America
Waltham, MA, US - Received
- October 7, 2015
- Decision date
- November 5, 2015
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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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|---|---|---|---|
| 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 |
| 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 |
| K121599 | Crit-Line Clip (Clic)KOC · Traditional | Fresenius Medical Care-North America | 11/09/2012SE |
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| K152367 | Optiflux dialyzerKDI · Traditional | 10/29/2015SE |
| K123262 | Optiflux Ultra DialyzerKDI · Traditional | 01/06/2014SE |
| K131611 | Fresenius Dry Acid Dissolution UnitsKPO · Traditional | 08/29/2013SE |
| K124035 | 2008K@HOME Hemodialysis MachineONW · Traditional | 07/03/2013SE |
| K121341 | Fresenius 2008T Hemodialysis Machine with Bibag SystemKDI · Traditional | 12/06/2012SE |
| K121599 | Crit-Line Clip (Clic)KOC · Traditional | 11/09/2012SE |
| K120017 | Fresenius 2008 Hemodiaysis Machine with Bibag SystemKDI · Special | 02/02/2012SE |
| K113427 | Fresenius 2008T Hemodialysis MachineKDI · Special | 12/21/2011SE |
Questions and answers
When was Crit-Line Clip (Clic) Blood Chamber cleared by the FDA?
Crit-Line Clip (Clic) Blood Chamber (K152953) received a 510(k) decision of Substantially Equivalent on November 5, 2015, 29 days after the submission was received.
What is the product code of K152953?
The FDA product code is KOC – Accessories, Blood Circuit, Hemodialysis, a Class II (moderate risk) device regulated under 21 CFR 876.5820.