Hemotherm Model 400CE Cooler/Heater System
FDA 510(k) K122813 · Cincinnati Sub-Zero Products, Inc.
510(k) numberK122813
Submission
- Device name
- Hemotherm Model 400CE Cooler/Heater System
- Applicant
- Cincinnati Sub-Zero Products, Inc.
Sharonville, OH, US - Received
- September 13, 2012
- Decision date
- December 18, 2012
- 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).
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| K140012 | Sorin FlexthermDWC · Special | Sorin Group Deutschland GmbH | 01/31/2014SE |
| K130300 | Heater-Cooler Unit Hcu 40DWC · Traditional | Maquet Cardiopulmonary, AG | 07/01/2013SE |
| 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 |
| K052601 | Stockert Heater-Cooler System 3TDWC · Traditional | Sorin Group Deutschland GmbH | 06/06/2006SE |
| 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 |
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Questions and answers
When was Hemotherm Model 400CE Cooler/Heater System cleared by the FDA?
Hemotherm Model 400CE Cooler/Heater System (K122813) received a 510(k) decision of Substantially Equivalent on December 18, 2012, 96 days after the submission was received.
What is the product code of K122813?
The FDA product code is DWC – Controller, Temperature, Cardiopulmonary Bypass, a Class II (moderate risk) device regulated under 21 CFR 870.4250.