| 510(k) Number |
BK940025 |
| Tradename |
Katzen Thrombolysis Guideware
|
| Original Applicant |
| Boston Scientific, Inc. |
| 1 boston scientific place |
|
natick,
MA
01760
1537
|
|
| Date Received | 05/24/1994 |
| Decision Date | 01/24/1996 |
| Decision |
substantially equivalent (SE) |
| Type |
510(k) Traditional
|
| Reviewed by Third Party |
No
|
| Expedited Review |
No
|
| Combination Product |
No
|
| In Vitro Product |
No
|
|
|