Device Classification Name |
Catheter, Percutaneous
|
510(k) Number |
K013789 |
Device Name |
EXCELSIOR SL-10 MICROCATHETER, MODELS 168581, 168381, 168181, 168189 |
Applicant |
BOSTON SCIENTIFIC, TARGET |
47900 BAYSIDE PKWY. |
FREMONT,
CA
94538
|
|
Applicant Contact |
GEORGE J PRENDERGAST |
Correspondent |
BOSTON SCIENTIFIC, TARGET |
47900 BAYSIDE PKWY. |
FREMONT,
CA
94538
|
|
Correspondent Contact |
GEORGE J PRENDERGAST |
Regulation Number | 870.1250
|
Classification Product Code |
|
Date Received | 11/14/2001 |
Decision Date | 12/06/2001 |
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
|
|
|