Device Classification Name |
Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
|
510(k) Number |
K941916 |
Device Name |
QUEST CORONARY SINUS PERFUSION CANNULA -FRCC |
Applicant |
QUEST MEDICAL, INC. |
ONE ALLENTOWN PKWY. |
ALLEN,
TX
75002
|
|
Applicant Contact |
DREW JOHNSON |
Correspondent |
QUEST MEDICAL, INC. |
ONE ALLENTOWN PKWY. |
ALLEN,
TX
75002
|
|
Correspondent Contact |
DREW JOHNSON |
Regulation Number | 870.4210
|
Classification Product Code |
|
Date Received | 04/19/1994 |
Decision Date | 04/06/1995 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|