Device Classification Name |
Catheter, Percutaneous
|
510(k) Number |
K042568 |
Device Name |
EXCELSIOR 1018 AND SL-10 MICROCATHETERS |
Applicant |
BOSTON SCIENTIFIC CORP. |
47900 BAYSIDE PARKWAY |
FREMONT,
CA
94538 -6515
|
|
Applicant Contact |
VICTOR HAM |
Correspondent |
BOSTON SCIENTIFIC CORP. |
47900 BAYSIDE PARKWAY |
FREMONT,
CA
94538 -6515
|
|
Correspondent Contact |
VICTOR HAM |
Regulation Number | 870.1250
|
Classification Product Code |
|
Date Received | 09/21/2004 |
Decision Date | 10/15/2004 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|