Heater-Cooler System 3T
FDA 510(k) K220635 · Livanova Deutschland, GmbH
510(k) numberK220635
Submission
- Device name
- Heater-Cooler System 3T
- Applicant
- Livanova Deutschland, GmbH
Munchen, DE - Received
- March 4, 2022
- Decision date
- November 16, 2022
- 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 |
|---|---|---|---|
| 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 |
| 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 |
More from Minntech Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K232291 | Essenz HLM, Essenz ILBMDTQ · Special | 08/24/2023SE |
| K221373 | Essenz HLMDTQ · Traditional | 03/09/2023SE |
| K212003 | ESSENZ Patient MonitorDXJ · Special | 11/10/2021SE |
| K210130 | Stockert S5 SystemDTQ · Special | 04/05/2021SE |
| K202154 | B-CaptaDRY · Traditional | 04/01/2021SE |
| K191402 | Heater-Cooler System 3TDWC · Traditional | 02/25/2020SE |
Questions and answers
When was Heater-Cooler System 3T cleared by the FDA?
Heater-Cooler System 3T (K220635) received a 510(k) decision of Substantially Equivalent on November 16, 2022, 257 days after the submission was received.
What is the product code of K220635?
The FDA product code is DWC – Controller, Temperature, Cardiopulmonary Bypass, a Class II (moderate risk) device regulated under 21 CFR 870.4250.