Sorin Centrifugal Pump 5 (CP5)
FDA 510(k) K112225 · Sorin Group Deutschland GmbH
510(k) numberK112225
Submission
- Device name
- Sorin Centrifugal Pump 5 (CP5)
- Applicant
- Sorin Group Deutschland GmbH
North Attleboro, MA, US - Received
- August 3, 2011
- Decision date
- September 20, 2011
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DWA – Control, Pump Speed, Cardiopulmonary Bypass
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.4380
- Specialty
- Cardiovascular
- Life-sustaining
- Yes
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| K230698 | Anivia SG1000 Pump ConsoleDWA · Special | Apmtd, Inc. | 04/18/2023SE |
| K221491 | Anivia SG1000 Pump ConsoleDWA · Traditional | Apmtd, Inc. | 02/03/2023SE |
| K192838 | Quantumn Centrifugal Drive- High Pressure, Quantum Centrifugal Drive- Medium PressureDWA · Traditional | Spectrum Medical , Ltd. | 04/13/2020SE |
| K200306 | CentriMag Circulatory Support System, CentriMag Return (Arterial) Cannula Kit, CentriMag…DWA · Special | Abbott (Formerly Thoratec Corporation) | 03/06/2020SE |
| K191557 | CentriMag Acute Circulatory Support SystemDWA · Special | Thoratec Corporation (Now Part of Abbott) | 07/10/2019SE |
| K131964 | Bio-Console 560 Extracorporeal Blood Pumping ConsoleDWA · Special | Medtronic, Inc. | 07/24/2013SE |
| K131179 | Centrimag Primary Console (2ND Generation); Mag MonitorDWA · Special | Thoratec Corp | 07/18/2013SE |
| K103468 | Stockert Centrifugal Pump (SCP Plus) (Complete) or (for S5/C5 Systems)DWA · Traditional | Sorin Group Deutschland GmbH | 01/20/2011SE |
| K102129 | Levitronix 2ND Generation Centrimag Primary Console, Levitronix MonitorDWA · Special | Levitronix, LLC | 08/27/2010SE |
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| K103762 | Sorin C5 System; 85/C5 Mast Roller Pump System 150(1X RP 150 and Control Panel with…DTQ · Special | 01/20/2011SE |
| K103468 | Stockert Centrifugal Pump (SCP Plus) (Complete) or (for S5/C5 Systems)DWA · Traditional | 01/20/2011SE |
| K103469 | Stockert Air Purge Control System Model 23-45-05KRL · Traditional | 01/18/2011SE |
| K103168 | B-CARE5 (B-CARE5 Sensor Module, Venous Sensor, Holder for Measuring Head)DRY · Traditional | 01/06/2011SE |
| K101046 | Stockert S5 System and Gas Blender and Sorin C5 SystemDTX · Traditional | 12/09/2010SE |
| K093882 | Sorin C5 System Model 58-00-00DTQ · Special | 01/15/2010SE |
Questions and answers
When was Sorin Centrifugal Pump 5 (CP5) cleared by the FDA?
Sorin Centrifugal Pump 5 (CP5) (K112225) received a 510(k) decision of Substantially Equivalent on September 20, 2011, 48 days after the submission was received.
What is the product code of K112225?
The FDA product code is DWA – Control, Pump Speed, Cardiopulmonary Bypass, a Class II (moderate risk) device regulated under 21 CFR 870.4380.