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Coeur, Inc.

FDA 510(k) & PMA Approved Devices — 10 products

Total Devices10
Categories0
Latest FDA decision
TypeNumberDevice NameCodeDateActions
510(k) K170431 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 TipDXT2017-08-18 View
510(k) K161471 MR Syringe Dual Pack for Solaris InjectorsDXT2016-10-06 View
510(k) K120892 DISPOSABLE 330PSI EXTENSION LINESDXT2013-06-10 View
510(k) K113498 DISPOSABLE TORQUE DEVICEDQX2012-07-20 View
510(k) K113132 DISPOSABLE HEMOSTATIC Y-CONNECTORSDTL2012-01-20 View
510(k) K090487 DISPOSABLE ANGIOGRAPHIC SYRINGES FOR USE WITH NEMOTO ANGIOGRAPHIC POWER, MODEL SY-125, C855-5150DXT2009-10-19 View
510(k) K070798 ADAPTERS FOR CT, ANGIOGRAPHIC, AND/OR MRI POWER INJECTORSDXT2007-10-04 View
510(k) K071196 DISPOSABLE HIGH PRESSURE INJECTION LINES WITH AND WITHOUT ROTATING ADAPTERSDQO2007-09-06 View
510(k) K063114 DISPOSABLE TRANSFER SETS WITH AND WITHOUT SWABBABLE VALVES AND/OR CHECK VALVESFPK2007-02-09 View
510(k) K051799 DISPOSABLE CT/MR SYRINGES FOR NEMOTO INJECTORSDXT2005-11-02 View
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