Device Classification Name |
catheter, intravascular, diagnostic
|
510(k) Number |
K060175 |
Device Name |
ISIGHT IMAGING CATHETER, MODEL 38986 |
Applicant |
BOSTON SCIENTIFIC CORP. |
47900 BAYSIDE PARKWAY |
FREMONT,
CA
94538
|
|
Applicant Contact |
ROBERT Z PHILLIPS |
Correspondent |
BOSTON SCIENTIFIC CORP. |
47900 BAYSIDE PARKWAY |
FREMONT,
CA
94538
|
|
Correspondent Contact |
ROBERT Z PHILLIPS |
Regulation Number | 870.1200
|
Classification Product Code |
|
Date Received | 01/23/2006 |
Decision Date | 03/24/2006 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|