Device Classification Name |
Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
|
510(k) Number |
K840603 |
Device Name |
ARTERIAL FILTER PURGE LINE W/CHECK VALV |
Applicant |
SHILEY, INC. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Correspondent |
SHILEY, INC. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Regulation Number | 870.4290
|
Classification Product Code |
|
Date Received | 02/10/1984 |
Decision Date | 04/19/1984 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|