Medical Device Manufacturer · US , Lebanon , TN

Coeur, Inc.

14 submissions · 14 cleared · Since 2005
14
Total
14
Cleared
0
Denied

Coeur, Inc. — FDA 510(k) Submissions

Coeur, Inc. has submitted 14 FDA 510(k) premarket notifications since 2005, of which 14 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Injector And Syringe, Angiographic, Tubing, Fluid Delivery, Catheter, Intravascular, Diagnostic, Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass, Wire, Guide, Catheter . Use the specialty filter in the sidebar to narrow results.

14 devices
1–14 of 14
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
K170431 · DXT Injector And Syringe,... · Cardiovascular
Aug 2017 186d
MR Syringe Dual Pack for Solaris Injectors
K161471 · DXT Injector And Syringe,... · Cardiovascular
Oct 2016 132d
330psi Extension Y-Line with Dual Check Valve
K150902 · DXT Injector And Syringe,... · Cardiovascular
Oct 2015 202d
125mL CT Syringe
K142745 · DXT Injector And Syringe,... · Cardiovascular
Apr 2015 189d
MR SYRINGE DUAL PACK
K140469 · DXT Injector And Syringe,... · Cardiovascular
Jul 2014 153d
COEUR, INC. FRONTLOAD FOR OPTIVANTAGE POWER INJECTOR
K133600 · DXT Injector And Syringe,... · Cardiovascular
Apr 2014 156d
DISPOSABLE 330PSI EXTENSION LINES
K120892 · DXT Injector And Syringe,... · Cardiovascular
Jun 2013 444d
DISPOSABLE TORQUE DEVICE
K113498 · DQX Wire, Guide, Catheter · Cardiovascular
Jul 2012 238d
DISPOSABLE HEMOSTATIC Y-CONNECTORS
K113132 · DTL Adaptor, Stopcock,... · Cardiovascular
Jan 2012 88d
DISPOSABLE ANGIOGRAPHIC SYRINGES FOR USE WITH NEMOTO ANGIOGRAPHIC POWER, MODEL SY-125, C855-5150
K090487 · DXT Injector And Syringe,... · Cardiovascular
Oct 2009 236d
ADAPTERS FOR CT, ANGIOGRAPHIC, AND/OR MRI POWER INJECTORS
K070798 · DXT Injector And Syringe,... · Cardiovascular
Oct 2007 195d
DISPOSABLE HIGH PRESSURE INJECTION LINES WITH AND WITHOUT ROTATING ADAPTERS
K071196 · DQO Catheter, Intravascular,... · Cardiovascular
Sep 2007 129d
DISPOSABLE TRANSFER SETS WITH AND WITHOUT SWABBABLE VALVES AND/OR CHECK VALVES
K063114 · FPK Tubing, Fluid Delivery · General Hospital
Feb 2007 121d
DISPOSABLE CT/MR SYRINGES FOR NEMOTO INJECTORS
K051799 · DXT Injector And Syringe,... · Cardiovascular
Nov 2005 120d
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