Device Classification Name |
catheter, intravascular, diagnostic
|
510(k) Number |
K040776 |
Device Name |
ATLANTIS SR, MODEL C4020; ATLANTIS SR PLUS, MODEL 35975 |
Applicant |
BOSTON SCIENTIFIC CORP. |
47900 BAYSIDE PARKWAY |
FREMONT,
CA
94538 -6515
|
|
Applicant Contact |
ROBERT Z PHILLIPS |
Correspondent |
BOSTON SCIENTIFIC CORP. |
47900 BAYSIDE PARKWAY |
FREMONT,
CA
94538 -6515
|
|
Correspondent Contact |
ROBERT Z PHILLIPS |
Regulation Number | 870.1200
|
Classification Product Code |
|
Date Received | 03/26/2004 |
Decision Date | 04/29/2004 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Statement |
Statement
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|