Stockert Centrifugal Pump System with Tubing Clamp
FDA 510(k) K032213 · Stockert Instrumente GmbH
510(k) numberK032213
Submission
- Device name
- Stockert Centrifugal Pump System with Tubing Clamp
- Applicant
- Stockert Instrumente GmbH
North Attleboro, MA, US - Received
- July 21, 2003
- Decision date
- August 29, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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 |
| K112225 | Sorin Centrifugal Pump 5 (CP5)DWA · Special | Sorin Group Deutschland GmbH | 09/20/2011SE |
| K103468 | Stockert Centrifugal Pump (SCP Plus) (Complete) or (for S5/C5 Systems)DWA · Traditional | Sorin Group Deutschland GmbH | 01/20/2011SE |
More from Sorin Group Deutschland GmbH
| 510(k) | Device | Decision |
|---|---|---|
| K042374 | Stockert SCP RhythmDWA · Special | 09/23/2004SE |
| K041558 | Stockertir Purge Control (Apc) SystemDTW · Special | 07/02/2004SE |
| K023622 | Stockert Pediatric Aortic Cannulae, Model Numbers A272-15 Through A272-35DWF · Abbreviated | 11/21/2002SE |
| K022280 | Stockert Coronary Perfusion CannulaeDWF · Abbreviated | 10/11/2002SE |
| K022321 | Stockert V172-28 Venous Femoral CannulaDWF · Traditional | 10/09/2002SE |
| K020571 | Stockert Centrifugal Pump ConsoleDTQ · Traditional | 09/23/2002SE |
| K011838 | Centrifugal PumpDWA · Traditional | 02/05/2002SE |
| K011088 | Siii Alarm AmplifierDTQ · Special | 05/02/2001SE |
Questions and answers
When was Stockert Centrifugal Pump System with Tubing Clamp cleared by the FDA?
Stockert Centrifugal Pump System with Tubing Clamp (K032213) received a 510(k) decision of Substantially Equivalent on August 29, 2003, 39 days after the submission was received.
What is the product code of K032213?
The FDA product code is DWA – Control, Pump Speed, Cardiopulmonary Bypass, a Class II (moderate risk) device regulated under 21 CFR 870.4380.