The following data is part of a premarket notification filed by Vascular Architects, Inc. with the FDA for Aspire Covered Stent And Delivery Catheter.
| Device ID | K003173 |
| 510k Number | K003173 |
| Device Name: | ASPIRE COVERED STENT AND DELIVERY CATHETER |
| Classification | Prosthesis, Esophageal |
| Applicant | VASCULAR ARCHITECTS, INC. 1830 BERING DR. San Jose, CA 95112 -4226 |
| Contact | Kevin F Macdonald |
| Correspondent | Kevin F Macdonald VASCULAR ARCHITECTS, INC. 1830 BERING DR. San Jose, CA 95112 -4226 |
| Product Code | ESW |
| CFR Regulation Number | 878.3610 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-10-10 |
| Decision Date | 2001-03-13 |