Device Classification Name |
Catheter, Intravascular, Diagnostic
|
510(k) Number |
K050684 |
Device Name |
ATLANTIS PV |
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 |
|
Subsequent Product Code |
|
Date Received | 03/17/2005 |
Decision Date | 05/20/2005 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Radiology
|
Statement |
Statement
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|