Device Classification Name |
catheter, intravascular, diagnostic
|
510(k) Number |
K063312 |
Device Name |
MODIFICATION TO ATLANTIS SR PRO 2 AND SR PRO CORONARY IMAGING CATHETERS, MODEL 39014 AND 38942 |
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 | 11/02/2006 |
Decision Date | 11/30/2006 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|