Medical Device Manufacturer · US , Lebanon , TN

Coeur, Inc. - FDA 510(k) Cleared Devices

14 submissions · 14 cleared · Since 2005

Recent clearances: 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, MR Syringe Dual Pack for Solaris Injectors, 330psi Extension Y-Line with Dual Check Valve

View 14 510(k) Devices ↓

14

Total

14

Cleared

0

Denied

FDA 510(k) Regulatory Record - Coeur, Inc. General Hospital ✕

1 devices

1-1 of 1

Cleared Feb 09, 2007

DISPOSABLE TRANSFER SETS WITH AND WITHOUT SWABBABLE VALVES AND/OR CHECK VALVES

General Hospital · 121d