Device Classification Name |
catheter, cannula and tubing, vascular, cardiopulmonary bypass
|
510(k) Number |
K030231 |
Device Name |
CORONARY ARTERY PERFUSION CANNULA WITH SELF-INFLATING BALLOON |
Applicant |
VITALCOR, INC. |
100 EAST CHESTNUT AVE. |
WESTMONT,
IL
60559
|
|
Applicant Contact |
WILLIAM HUCK |
Correspondent |
VITALCOR, INC. |
100 EAST CHESTNUT AVE. |
WESTMONT,
IL
60559
|
|
Correspondent Contact |
WILLIAM HUCK |
Regulation Number | 870.4210
|
Classification Product Code |
|
Date Received | 01/22/2003 |
Decision Date | 04/18/2003 |
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
|
|
|