Stopcock, One Way
FDA 510(k) K770383 · Cobe Laboratories, Inc.
510(k) numberK770383
Submission
- Device name
- Stopcock, One Way
- Applicant
- Cobe Laboratories, Inc.
Mchenry, IL, US - Received
- February 28, 1977
- Decision date
- March 7, 1977
- 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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| 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 |
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| K902631 | Cobe ICU Conversion KitDTN · Traditional | 12/17/1990SE |
| K902437 | Cobe Cardiotomy Reservoir with or Without FilterDTP · Traditional | 12/17/1990SE |
| K904566 | New Cobe Centrysystem(Tm) 100 HG DialyzerFJI · Traditional | 12/12/1990SE |
| K902758 | Cobe Saturation/Hematocrit Monitor W/ Fiber OpticDQA · Traditional | 08/23/1990SE |
| K902759 | Cobe Closed Wound Drainage KitCAC · Traditional | 07/18/1990SE |
Questions and answers
When was Stopcock, One Way cleared by the FDA?
Stopcock, One Way (K770383) received a 510(k) decision of Substantially Equivalent on March 7, 1977, 7 days after the submission was received.
What is the product code of K770383?
The FDA product code is KOC – Accessories, Blood Circuit, Hemodialysis, a Class II (moderate risk) device regulated under 21 CFR 876.5820.