Ecmo-Temp (TM) Blood Warming Device
FDA 510(k) K873699 · Seabrook Medical Systems, Inc.
510(k) numberK873699
Submission
- Device name
- Ecmo-Temp (TM) Blood Warming Device
- Applicant
- Seabrook Medical Systems, Inc.
Cincinnati, OH, US - Received
- September 16, 1987
- Decision date
- December 22, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
| 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 |
More from Jostra AB
| 510(k) | Device | Decision |
|---|---|---|
| K952086 | Tropicair Convective Warming BlanketsDWJ · Traditional | 09/06/1995SE |
| K946196 | Tropicair Convective Waring SystemDWJ · Traditional | 09/06/1995SE |
| K931203 | Cool-AidILO · Traditional | 02/22/1994SE |
| K923104 | Tropic-AirDWJ · Traditional | 07/13/1993SE |
| K914182 | Golden Thermal(R)ILO · Traditional | 10/18/1991SE |
| K902756 | Tropi-CoolDWJ · Traditional | 10/22/1990SE |
| K902269 | Electri-Cool(Tm) Liquid-Circulat. Thermal TherapyILO · Traditional | 06/21/1990SE |
| K902268 | Pedia-Temp(Tm) Liquid-Circulating Hypo-Hypertherm.ILO · Traditional | 06/21/1990SE |
| K882310 | Dual-Temp(Tm) Cooling/Warming UnitILO · Traditional | 09/23/1988SE |
| K881322 | Mini-Temp(Tm)DWJ · Traditional | 06/22/1988SE |
Questions and answers
When was Ecmo-Temp (TM) Blood Warming Device cleared by the FDA?
Ecmo-Temp (TM) Blood Warming Device (K873699) received a 510(k) decision of Substantially Equivalent on December 22, 1987, 97 days after the submission was received.
What is the product code of K873699?
The FDA product code is DWC – Controller, Temperature, Cardiopulmonary Bypass, a Class II (moderate risk) device regulated under 21 CFR 870.4250.