K012544 is an FDA 510(k) clearance for the VASCULAR ARCHITECTS ASPIRE COVERED STENT AND CONTROLLED EXPANSION DELIVERY SYSTEM. This device is classified as a Prosthesis, Tracheal, Expandable (Class II — Special Controls, product code JCT).
Submitted by Vascular Architects, Inc. (San Jose, US). The FDA issued a Cleared decision on November 15, 2001, 100 days after receiving the submission on August 7, 2001.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.3720.
| 510(k) Number | K012544 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | August 07, 2001 |
| Decision Date | November 15, 2001 |
| Days to Decision | 100 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | JCT — Prosthesis, Tracheal, Expandable |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 878.3720 |