Device Classification Name |
prosthesis, vascular graft, of 6mm and greater diameter |
|||
---|---|---|---|---|
510(k) Number | K051332 | |||
Device Name | ADVANTA T-GRAFT | |||
Applicant |
|
|||
Applicant Contact | karen hall | |||
Correspondent |
|
|||
Correspodent Contact | karen hall | |||
Regulation Number | 870.3450 | |||
Classification Product Code |
|
|||
Date Received | 05/23/2005 | |||
Decision Date | 09/29/2005 | |||
Decision |
substantially equivalent (SESE) |
|||
Regulation Medical Specialty |
Cardiovascular |
|||
510k Review Panel |
Cardiovascular |
|||
statement |
statement |
|||
Type | Traditional | |||
Reviewed by Third Party | No | |||
Combination Product |
No |
|||
Recalls | CDRH Recalls |