| Device Classification Name |
catheter, peripheral, atherectomy |
|||
|---|---|---|---|---|
| 510(k) Number | K111229 | |||
| Device Name | JETSTREAM G3 (R) SF 1.6 SYSTEM | |||
| Applicant |
|
|||
| Applicant Contact | cyndy adams | |||
| Correspondent |
|
|||
| Correspodent Contact | cyndy adams | |||
| Regulation Number | 870.4875 | |||
| Classification Product Code |
|
|||
| Date Received | 05/02/2011 | |||
| Decision Date | 06/01/2011 | |||
| Decision |
substantially equivalent (SESE) |
|||
| Regulation Medical Specialty |
Cardiovascular |
|||
| 510k Review Panel |
Cardiovascular |
|||
| summary |
summary |
|||
| Type | Special | |||
| Clinical Trials | NCT00676494 | |||
| Reviewed by Third Party | No | |||
| Combination Product |
No |