The following data is part of a premarket notification filed by Vascular Architects, Inc. with the FDA for Vascular Architects Aspire Covered Stent And 718 Delivery System.
| Device ID | K031641 |
| 510k Number | K031641 |
| Device Name: | VASCULAR ARCHITECTS ASPIRE COVERED STENT AND 718 DELIVERY SYSTEM |
| Classification | Prosthesis, Tracheal, Expandable |
| Applicant | VASCULAR ARCHITECTS, INC. 1830 BERING DR. San Jose, CA 95112 -4226 |
| Contact | Phyllis Elson |
| Correspondent | Phyllis Elson VASCULAR ARCHITECTS, INC. 1830 BERING DR. San Jose, CA 95112 -4226 |
| Product Code | JCT |
| CFR Regulation Number | 878.3720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-05-27 |
| Decision Date | 2003-08-01 |
| Summary: | summary |