MEDRAD MARK 7 ARTERION (PEDESTAL SYSTEM / TABLE MOUNT SYSTEM), MEDRAD MARK 7 ARTERION SYRINGE


Device Classification Name

injector and syringe, angiographic

510(k) Number K112086
Device Name MEDRAD MARK 7 ARTERION (PEDESTAL SYSTEM / TABLE MOUNT SYSTEM), MEDRAD MARK 7 ARTERION SYRINGE
Applicant
MEDRAD, INC.
one medrad dr.
indianola, 
PA 
15051

Applicant Contact mike burnside
Correspondent
MEDRAD, INC.
one medrad dr.
indianola, 
PA 
15051

Correspodent Contact mike burnside
Regulation Number 870.1650
Classification Product Code
DXT  
Date Received 07/21/2011
Decision Date 10/14/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No