Coeur, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
14
Inspections
5
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K170431CT Syringe for Stellant Injectors (with & without Spikes, Prime Tubes, & Fill Tubes), CT Syringe DuaAugust 18, 2017
K161471MR Syringe Dual Pack for Solaris InjectorsOctober 6, 2016
K150902330psi Extension Y-Line with Dual Check ValveOctober 22, 2015
K142745125mL CT SyringeApril 1, 2015
K140469MR SYRINGE DUAL PACKJuly 28, 2014
K133600COEUR, INC. FRONTLOAD FOR OPTIVANTAGE POWER INJECTORApril 30, 2014
K120892DISPOSABLE 330PSI EXTENSION LINESJune 10, 2013
K113498DISPOSABLE TORQUE DEVICEJuly 20, 2012
K113132DISPOSABLE HEMOSTATIC Y-CONNECTORSJanuary 20, 2012
K090487DISPOSABLE ANGIOGRAPHIC SYRINGES FOR USE WITH NEMOTO ANGIOGRAPHIC POWER, MODEL SY-125, C855-5150October 19, 2009
K070798ADAPTERS FOR CT, ANGIOGRAPHIC, AND/OR MRI POWER INJECTORSOctober 4, 2007
K071196DISPOSABLE HIGH PRESSURE INJECTION LINES WITH AND WITHOUT ROTATING ADAPTERSSeptember 6, 2007
K063114DISPOSABLE TRANSFER SETS WITH AND WITHOUT SWABBABLE VALVES AND/OR CHECK VALVESFebruary 9, 2007
K051799DISPOSABLE CT/MR SYRINGES FOR NEMOTO INJECTORSNovember 2, 2005