Coeur, Inc.
Coeur, Inc. appears in FDA public data with 0 recalls, 14 510(k) clearances, 5 FDA inspections, and 0 compliance actions on record. Its most recent 510(k) clearance was granted on August 18, 2017.
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 14
- Inspections
- 5
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|---|---|
| K170431 | CT Syringe for Stellant Injectors (with & without Spikes, Prime Tubes, & Fill Tubes), CT Syringe Dua | August 18, 2017 |
| K161471 | MR Syringe Dual Pack for Solaris Injectors | October 6, 2016 |
| K150902 | 330psi Extension Y-Line with Dual Check Valve | October 22, 2015 |
| K142745 | 125mL CT Syringe | April 1, 2015 |
| K140469 | MR SYRINGE DUAL PACK | July 28, 2014 |
| K133600 | COEUR, INC. FRONTLOAD FOR OPTIVANTAGE POWER INJECTOR | April 30, 2014 |
| K120892 | DISPOSABLE 330PSI EXTENSION LINES | June 10, 2013 |
| K113498 | DISPOSABLE TORQUE DEVICE | July 20, 2012 |
| K113132 | DISPOSABLE HEMOSTATIC Y-CONNECTORS | January 20, 2012 |
| K090487 | DISPOSABLE ANGIOGRAPHIC SYRINGES FOR USE WITH NEMOTO ANGIOGRAPHIC POWER, MODEL SY-125, C855-5150 | October 19, 2009 |
| K070798 | ADAPTERS FOR CT, ANGIOGRAPHIC, AND/OR MRI POWER INJECTORS | October 4, 2007 |
| K071196 | DISPOSABLE HIGH PRESSURE INJECTION LINES WITH AND WITHOUT ROTATING ADAPTERS | September 6, 2007 |
| K063114 | DISPOSABLE TRANSFER SETS WITH AND WITHOUT SWABBABLE VALVES AND/OR CHECK VALVES | February 9, 2007 |
| K051799 | DISPOSABLE CT/MR SYRINGES FOR NEMOTO INJECTORS | November 2, 2005 |