Device Classification Name |
Catheter, Intravascular, Diagnostic
|
510(k) Number |
K984627 |
Device Name |
AVE 4F SITESEER CARDIOVASCULAR ANGIOGRAPHIC CATHETER |
Applicant |
ARTERIAL VASCULAR ENGINEERING, INC. |
129 CONCORD RD. |
BILLERICA,
MA
01821
|
|
Applicant Contact |
DEBORAH L HERRINGTON |
Correspondent |
ARTERIAL VASCULAR ENGINEERING, INC. |
129 CONCORD RD. |
BILLERICA,
MA
01821
|
|
Correspondent Contact |
DEBORAH L HERRINGTON |
Regulation Number | 870.1200 |
Classification Product Code |
|
Date Received | 12/30/1998 |
Decision Date | 07/27/1999 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|