ClearanceBrief
Company ยท US

Coeur, Inc.

FDA 510(k) clearances and medical device recalls filed under this name, 2005 to 2017. Name variants (Inc, Corp, punctuation) are merged.

14510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)

Product codes

CodeDeviceRecords
DXTInjector And Syringe, Angiographic10
DQOCatheter, Intravascular, Diagnostic1
DQXWire, Guide, Catheter1
DTLAdaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass1
FPKTubing, Fluid Delivery1

Latest 510(k) clearances

Decided510(k)Device and applicantCode
Aug 18, 2017K170431CT Syringe for Stellant Injectors (with & without Spikes, Prime Tubes, & Fill Tubes), CT Syringe Dual Pack for Stellant
Coeur, Inc.
DXT
Oct 6, 2016K161471MR Syringe Dual Pack for Solaris Injectors
Coeur, Inc.
DXT
Oct 22, 2015K150902330psi Extension Y-Line with Dual Check Valve
Coeur, Inc.
DXT
Apr 1, 2015K142745125mL CT Syringe
Coeur, Inc.
DXT
Jul 28, 2014K140469MR SYRINGE DUAL PACK
Coeur, Inc.
DXT
Apr 30, 2014K133600COEUR, INC. FRONTLOAD FOR OPTIVANTAGE POWER INJECTOR
Coeur, Inc.
DXT
Jun 10, 2013K120892DISPOSABLE 330PSI EXTENSION LINES
Coeur, Inc.
DXT
Jul 20, 2012K113498DISPOSABLE TORQUE DEVICE
Coeur, Inc.
DQX
Jan 20, 2012K113132DISPOSABLE HEMOSTATIC Y-CONNECTORS
Coeur, Inc.
DTL
Oct 19, 2009K090487DISPOSABLE ANGIOGRAPHIC SYRINGES FOR USE WITH NEMOTO ANGIOGRAPHIC POWER, MODEL SY-125, C855-5150
Coeur, Inc.
DXT
Oct 4, 2007K070798ADAPTERS FOR CT, ANGIOGRAPHIC, AND/OR MRI POWER INJECTORS
Coeur, Inc.
DXT
Sep 6, 2007K071196DISPOSABLE HIGH PRESSURE INJECTION LINES WITH AND WITHOUT ROTATING ADAPTERS
Coeur, Inc.
DQO
Feb 9, 2007K063114DISPOSABLE TRANSFER SETS WITH AND WITHOUT SWABBABLE VALVES AND/OR CHECK VALVES
Coeur, Inc.
FPK
Nov 2, 2005K051799DISPOSABLE CT/MR SYRINGES FOR NEMOTO INJECTORS
Coeur, Inc.
DXT

Latest recalls

DateFirm and productCodeLinked 510(k)
No recalls in this window.
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