Device Classification Name |
Injector And Syringe, Angiographic
|
510(k) Number |
K050456 |
Device Name |
MEDRAD AVANTA FLUID MANAGEMENT INJECTION SYSTEM |
Applicant |
MEDRAD, INC. |
ONE MEDRAD DR. |
INDIANOLA,
PA
15051
|
|
Applicant Contact |
GEOFF M FATZINGER |
Correspondent |
MEDRAD, INC. |
ONE MEDRAD DR. |
INDIANOLA,
PA
15051
|
|
Correspondent Contact |
GEOFF M FATZINGER |
Regulation Number | 870.1650
|
Classification Product Code |
|
Date Received | 02/23/2005 |
Decision Date | 06/17/2005 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|