FDA 510(k) Applications Submitted by Coeur, Inc.
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K090487 |
02/25/2009 |
DISPOSABLE ANGIOGRAPHIC SYRINGES FOR USE WITH NEMOTO ANGIOGRAPHIC POWER, MODEL SY-125, C855-5150 |
COEUR, INC. |
| K070798 |
03/23/2007 |
ADAPTERS FOR CT, ANGIOGRAPHIC, AND/OR MRI POWER INJECTORS |
COEUR, INC. |
| K120892 |
03/23/2012 |
DISPOSABLE 330PSI EXTENSION LINES |
COEUR, INC. |
| K071196 |
04/30/2007 |
DISPOSABLE HIGH PRESSURE INJECTION LINES WITH AND WITHOUT ROTATING ADAPTERS |
COEUR, INC. |
| K051799 |
07/05/2005 |
DISPOSABLE CT/MR SYRINGES FOR NEMOTO INJECTORS |
COEUR, INC. |
| K063114 |
10/11/2006 |
DISPOSABLE TRANSFER SETS WITH AND WITHOUT SWABBABLE VALVES AND/OR CHECK VALVES |
COEUR, INC. |
| K113132 |
10/24/2011 |
DISPOSABLE HEMOSTATIC Y-CONNECTORS |
COEUR, INC. |
| K113498 |
11/25/2011 |
DISPOSABLE TORQUE DEVICE |
COEUR, INC. |
| K133600 |
11/25/2013 |
COEUR, INC. FRONTLOAD FOR OPTIVANTAGE POWER INJECTOR |
COEUR, INC. |
| K140469 |
02/25/2014 |
MR SYRINGE DUAL PACK |
COEUR, INC. |
| K150902 |
04/03/2015 |
330psi Extension Y-Line with Dual Check Valve |
COEUR, INC. |
| K142745 |
09/24/2014 |
125mL CT Syringe |
COEUR, INC. |
| K170431 |
02/13/2017 |
CT Syringe for Stellant Injectors (with & without Spikes, Prime Tubes, & Fill Tubes), CT Syringe Dual Pack for Stellant Injectors (with & without Spikes, Prime Tubes, & Fill Tubes), Single Fascia and Ram Tip, Dual Fascia and Ram Tip |
Coeur, Inc. |
| K161471 |
05/27/2016 |
MR Syringe Dual Pack for Solaris Injectors |
Coeur, Inc. |
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