Device Classification Name |
injector and syringe, angiographic
|
510(k) Number |
K082905 |
Device Name |
MEDRAD STELLANT CT INJECTOR SYSTEM WITH P3T CARDIAC |
Applicant |
MEDRAD, INC. |
ONE MEDRAD DR. |
INDIANOLA,
PA
15051
|
|
Applicant Contact |
FORTUNATO ALDAPE |
Correspondent |
MEDRAD, INC. |
ONE MEDRAD DR. |
INDIANOLA,
PA
15051
|
|
Correspondent Contact |
FORTUNATO ALDAPE |
Regulation Number | 870.1650
|
Classification Product Code |
|
Date Received | 09/30/2008 |
Decision Date | 01/12/2009 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|