| Device Classification Name |
catheter, percutaneous |
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|---|---|---|---|---|
| 510(k) Number | K131493 | |||
| Device Name | SIDEKICK AND USHER SUPPORT CATHETERS | |||
| Applicant |
|
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| Applicant Contact | timothy wade | |||
| Regulation Number | 870.1250 | |||
| Classification Product Code |
|
|||
| Date Received | 05/23/2013 | |||
| Decision Date | 08/02/2013 | |||
| Decision |
substantially equivalent (SESE) |
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| Regulation Medical Specialty |
Cardiovascular |
|||
| 510k Review Panel |
Cardiovascular |
|||
| summary |
summary |
|||
| Type | Traditional | |||
| Reviewed by Third Party | Yes | |||
| Combination Product |
No |