MEDRAD STELLANT CT INJECTOR SYSTEM WITH P3T


Device Classification Name

injector and syringe, angiographic

510(k) Number K072886
Device Name MEDRAD STELLANT CT INJECTOR SYSTEM WITH P3T
Applicant
MEDRAD, INC.
one medrad dr.
indianola, 
PA 
15051

Applicant Contact lisa m casavant
Correspondent
MEDRAD, INC.
one medrad dr.
indianola, 
PA 
15051

Correspodent Contact lisa m casavant
Regulation Number 870.1650
Classification Product Code
DXT  
Date Received 10/09/2007
Decision Date 12/21/2007
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No