Device Classification Name |
Catheter, Intravascular, Diagnostic
|
510(k) Number |
K000743 |
Device Name |
BOSTON SCIENTIFIC SCIMED ATLANTIS CORONARY IMAGING CATHETER, MODEL C4020 |
Applicant |
BOSTON SCIENTIFIC SCIMED, INC. |
ONE SCIMED PLACE |
MAPLE GROVE,
MN
55311 -1566
|
|
Applicant Contact |
DEBORAH A FRANK |
Correspondent |
BOSTON SCIENTIFIC SCIMED, INC. |
ONE SCIMED PLACE |
MAPLE GROVE,
MN
55311 -1566
|
|
Correspondent Contact |
DEBORAH A FRANK |
Regulation Number | 870.1200
|
Classification Product Code |
|
Date Received | 03/07/2000 |
Decision Date | 09/06/2000 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|