Stockert Heater-Cooler System 3T
FDA 510(k) K052601 · Sorin Group Deutschland GmbH
510(k) numberK052601
Submission
- Device name
- Stockert Heater-Cooler System 3T
- Applicant
- Sorin Group Deutschland GmbH
North Attleboro, MA, US - Received
- September 21, 2005
- Decision date
- June 6, 2006
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DWC – Controller, Temperature, Cardiopulmonary Bypass
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.4250
- Specialty
- Cardiovascular
- Life-sustaining
- Yes
If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
Other 510(k)s with product code DWC
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K220635 | Heater-Cooler System 3TDWC · Traditional | Livanova Deutschland, GmbH | 11/16/2022SE |
| K212657 | Quantum Heater-CoolerDWC · Traditional | Spectrum Medical , Ltd. | 05/06/2022SE |
| K191402 | Heater-Cooler System 3TDWC · Traditional | Livanova Deutschland, GmbH | 02/25/2020SE |
| K140012 | Sorin FlexthermDWC · Special | Sorin Group Deutschland GmbH | 01/31/2014SE |
| K130300 | Heater-Cooler Unit Hcu 40DWC · Traditional | Maquet Cardiopulmonary, AG | 07/01/2013SE |
| K122813 | Hemotherm Model 400CE Cooler/Heater SystemDWC · Traditional | Cincinnati Sub-Zero Products, Inc. | 12/18/2012SE |
| K102147 | Cardioquip Modular Cooler-Heater Model MCH-1000DWC · Traditional | Cardioquip Llp | 11/19/2010SE |
| K071521 | Terumo HX2 Temperature Management SystemDWC · Traditional | Terumo Cardiovascular Systems Corp. | 11/21/2007SE |
| K031544 | Heater Cooler Unit, Model Hcu 30DWC · Traditional | Jostra AB | 08/07/2003SE |
| K014016 | Enguard CHC Dual Reservoir Cardioplegia Heater/CoolerDWC · Traditional | Minntech Corp. | 02/01/2002SE |
More from Minntech Corp.
| 510(k) | Device | Decision |
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| K170460 | Sorin ConnectDXJ · Special | 06/08/2017SE |
| K131553 | XtraCAC · Traditional | 03/21/2014SE |
| K140012 | Sorin FlexthermDWC · Special | 01/31/2014SE |
| K131816 | Sorin Connect Data Management SystemDXJ · Traditional | 07/23/2013SE |
| K112225 | Sorin Centrifugal Pump 5 (CP5)DWA · Special | 09/20/2011SE |
| 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 |
Questions and answers
When was Stockert Heater-Cooler System 3T cleared by the FDA?
Stockert Heater-Cooler System 3T (K052601) received a 510(k) decision of Substantially Equivalent on June 6, 2006, 258 days after the submission was received.
What is the product code of K052601?
The FDA product code is DWC – Controller, Temperature, Cardiopulmonary Bypass, a Class II (moderate risk) device regulated under 21 CFR 870.4250.