Medical Device Manufacturer · US , NC

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

10 submissions · 10 cleared · Since 1983

10

Total

10

Cleared

0

Denied

FDA 510(k) Regulatory Record - Coeur Laboratories, Inc. Cardiovascular ✕

6 devices

1-6 of 6

Cleared Oct 08, 1997

COEUR 130 ML ANGIOGRAPHIC SYRINGE

Cardiovascular · 152d

Cleared Mar 28, 1997

COEUR FRONT LOAD INJECTOR RETROFIT KIT (C859-0002)

Cardiovascular · 88d

Cleared Sep 12, 1996

FRONT LOAD INJECTOR TURRET MODEL 859-0001/200 ML FRONT LOAD SYRINGE MODEL...

Cardiovascular · 185d

Cleared Jun 22, 1989

PCA-10, 10CC DISP. ANGIOGRAPHY CONTROL SYRINGE

Cardiovascular · 154d

Cleared Nov 12, 1987

TUBING, POLYETHYLENE

Cardiovascular · 69d

Cleared Feb 18, 1983

COEURLOCK STERILE DISPOS. ANGIOGRAPHIC

Cardiovascular · 52d