Coeur, Inc.
Medical device manufacturer in Lebanon, TN.
14510(k) clearances
0PMA approvals
0recalls
Device types
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K170431 | CT Syringe for Stellant Injectors (with & without Spikes, Prime Tubes, & Fill Tubes), CT…DXT · Traditional | 08/18/2017SE |
| K161471 | MR Syringe Dual Pack for Solaris InjectorsDXT · Traditional | 10/06/2016SE |
| K150902 | 330psi Extension Y-Line with Dual Check ValveDXT · Traditional | 10/22/2015SE |
| K142745 | 125mL CT SyringeDXT · Traditional | 04/01/2015SE |
| K140469 | MR Syringe Dual PackDXT · Traditional | 07/28/2014SE |
| K133600 | Coeur, Inc. Frontload for Optivantage Power InjectorDXT · Traditional | 04/30/2014SE |
| K120892 | Disposable 330PSI Extension LinesDXT · Traditional | 06/10/2013SE |
| K113498 | Disposable Torque DeviceDQX · Traditional | 07/20/2012SE |
| K113132 | Disposable Hemostatic Y-ConnectorsDTL · Traditional | 01/20/2012SE |
| K090487 | Disposable Angiographic Syringes for Use with Nemoto Angiographic Power, Model SY-125…DXT · Traditional | 10/19/2009SE |
| K070798 | Adapters for CT, Angiographic, And/Or MRI Power InjectorsDXT · Traditional | 10/04/2007SE |
| K071196 | Disposable High Pressure Injection Lines with and Without Rotating AdaptersDQO · Traditional | 09/06/2007SE |
| K063114 | Disposable Transfer Sets with and Without Swabbable Valves And/Or Check ValvesFPK · Abbreviated | 02/09/2007SE |
| K051799 | Disposable Ct/Mr Syringes for Nemoto InjectorsDXT · Traditional | 11/02/2005SE |