MEDRAD STELLANT CT INJECTOR SYSTEM


Device Classification Name

injector and syringe, angiographic

510(k) Number K023183
Device Name MEDRAD STELLANT CT INJECTOR SYSTEM
Original Applicant
MEDRAD, INC.
one medrad dr.
indianola, 
PA 
15051

Original Contact frank w pelc iii
Regulation Number 870.1650
Classification Product Code
DXT  
Date Received 09/24/2002
Decision Date 01/10/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls