Device Classification Name |
prosthesis, tracheal, expandable
|
510(k) Number |
K030567 |
Device Name |
MODIFICATION TO VASCULAR ARCHITECTS ASPIRE COVERED STENT AND CONTRILLED EXPANSION DELIVERY SYSTEM |
Applicant |
VASCULAR ARCHITECTS, INC. |
1830 BERING DR. |
SAN JOSE,
CA
95112 -4226
|
|
Applicant Contact |
PHYLLIS ELSON |
Correspondent |
VASCULAR ARCHITECTS, INC. |
1830 BERING DR. |
SAN JOSE,
CA
95112 -4226
|
|
Correspondent Contact |
PHYLLIS ELSON |
Regulation Number | 878.3720
|
Classification Product Code |
|
Date Received | 02/24/2003 |
Decision Date | 03/24/2003 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|