Coeur, Inc. - FDA 510(k) Cleared Devices
14
Total
14
Cleared
0
Denied
Coeur, Inc. has 14 FDA 510(k) cleared cardiovascular devices. Based in Lebanon, US.
Historical record: 14 cleared submissions from 2005 to 2017.
Browse the complete list of FDA 510(k) cleared cardiovascular devices from this manufacturer. Filter by specialty or product code using the sidebar.
FDA 510(k) Regulatory Record - Coeur, Inc.
14 devices
Cleared
Aug 18, 2017
CT Syringe for Stellant Injectors (with & without Spikes, Prime Tubes, & Fill...
Cardiovascular
186d
Cleared
Oct 06, 2016
MR Syringe Dual Pack for Solaris Injectors
Cardiovascular
132d
Cleared
Oct 22, 2015
330psi Extension Y-Line with Dual Check Valve
Cardiovascular
202d
Cleared
Apr 01, 2015
125mL CT Syringe
Cardiovascular
189d
Cleared
Jul 28, 2014
MR SYRINGE DUAL PACK
Cardiovascular
153d
Cleared
Apr 30, 2014
COEUR, INC. FRONTLOAD FOR OPTIVANTAGE POWER INJECTOR
Cardiovascular
156d
Cleared
Jun 10, 2013
DISPOSABLE 330PSI EXTENSION LINES
Cardiovascular
444d
Cleared
Jul 20, 2012
DISPOSABLE TORQUE DEVICE
Cardiovascular
238d
Cleared
Jan 20, 2012
DISPOSABLE HEMOSTATIC Y-CONNECTORS
Cardiovascular
88d
Cleared
Oct 19, 2009
DISPOSABLE ANGIOGRAPHIC SYRINGES FOR USE WITH NEMOTO ANGIOGRAPHIC POWER,...
Cardiovascular
236d
Cleared
Oct 04, 2007
ADAPTERS FOR CT, ANGIOGRAPHIC, AND/OR MRI POWER INJECTORS
Cardiovascular
195d
Cleared
Sep 06, 2007
DISPOSABLE HIGH PRESSURE INJECTION LINES WITH AND WITHOUT ROTATING ADAPTERS
Cardiovascular
129d