| Device Classification Name |
catheter, cannula and tubing, vascular, cardiopulmonary bypass |
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|---|---|---|---|---|
| 510(k) Number | K110980 | |||
| Device Name | CENTRIMAG RETURN CANNULA KIT | |||
| Applicant |
|
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| Applicant Contact | lydia sakakeeny | |||
| Correspondent |
|
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| Correspodent Contact | lydia sakakeeny | |||
| Regulation Number | 870.4210 | |||
| Classification Product Code |
|
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| Date Received | 04/07/2011 | |||
| Decision Date | 06/20/2011 | |||
| Decision |
substantially equivalent (SESE) |
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| Regulation Medical Specialty |
Cardiovascular |
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| 510k Review Panel |
Cardiovascular |
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| summary |
summary |
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| Type | Traditional | |||
| Reviewed by Third Party | No | |||
| Combination Product |
No |