Medivance, Inc.
Medical device manufacturer in Louisville, CO.
12510(k) clearances
0PMA approvals
2recalls
Device types
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K251974 | Arctic Sun Temperature Management System (Model 5000)DWJ · Traditional | 10/24/2025SE |
| K243942 | Arctic Sun Stat Temperature Management SystemDWJ · Traditional | 04/30/2025SE |
| K200225 | Arctic Sun Stat Temperature Management SystemDWJ · Special | 02/28/2020SE |
| K161602 | Arctic Sun Temperature Management SystemDWJ · Special | 09/02/2016SE |
| K142702 | Arctic Sun Temperature Management System, ArcticGel Pads (Universal, XXS, XS, S, M and…DWJ · Traditional | 12/18/2014SE |
| K120849 | Hybrid Arcticgel PadDWJ · Traditional | 07/20/2012SE |
| K110956 | Medivance Nasogastric Tube Temperature SensorFLL · Traditional | 07/18/2011SE |
| K101092 | Arctic Sun Temperature Management System, Model 5000DWJ · Traditional | 07/16/2010SE |
| K080899 | Arctic Blast Intravenous Fluid ChillerNCX · Traditional | 08/07/2008SE |
| K071341 | Modification to Arctic Sun Temperature Management System, Model 2000DWJ · Special | 08/03/2007SE |
| K010338 | Artic Sun Temperature Management System, Model 200DWJ · Special | 03/07/2001SE |
| K002577 | Arctic Sun Temperature Management System, Model 100 Control Unit and Patient Energy…DWJ · Traditional | 10/26/2000SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-2457-2024 Class II | Arctic Sun Temperature Management Systems, Name/REF: Arctic Sun STAT, NA/6000-00-00…If temperature management system fails to reach correct target water temperature while device is operating… | 06/27/2024Open, Classified |
| Z-1381-2024 Class II | Medivance Neonatal ArcticGel Pads, REF: 31802, 3180202, 31802CNeonatal pads are experiencing reduced water flow, which may reduce or prevent water heating or cooling… | 02/16/2024Open, Classified |