Device Classification Name |
catheter, cannula and tubing, vascular, cardiopulmonary bypass
|
510(k) Number |
K964198 |
Device Name |
CAHSE AORTIC ROOT CANNULA |
Applicant |
CHASE MEDICAL, INC. |
1876 FIRMAN DR. |
RICHARDSON,
TX
75081
|
|
Applicant Contact |
BERT DAVIS |
Correspondent |
CHASE MEDICAL, INC. |
1876 FIRMAN DR. |
RICHARDSON,
TX
75081
|
|
Correspondent Contact |
BERT DAVIS |
Regulation Number | 870.4210
|
Classification Product Code |
|
Date Received | 10/21/1996 |
Decision Date | 03/19/1997 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|