Device Classification Name |
catheter, cannula and tubing, vascular, cardiopulmonary bypass
|
510(k) Number |
K851323 |
Device Name |
AMENDMENT WILLIAM HARVEY H-4300 CARDIOPULMONARY SU |
Applicant |
C.R. BARD, INC. |
111 SPRING ST. |
MURRAY HILL,
NJ
07974
|
|
Applicant Contact |
CATHERINE V BEATH |
Correspondent |
C.R. BARD, INC. |
111 SPRING ST. |
MURRAY HILL,
NJ
07974
|
|
Correspondent Contact |
CATHERINE V BEATH |
Regulation Number | 870.4210
|
Classification Product Code |
|
Date Received | 04/04/1985 |
Decision Date | 08/12/1985 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|