K020767 is an FDA 510(k) clearance for the ADVANTA SST BIFURCATED GRAFT. This device is classified as a Prosthesis, Vascular Graft, Of 6mm And Greater Diameter (Class II - Special Controls, product code DSY).
Submitted by Atrium Medical Corp. (Hudson, US). The FDA issued a Cleared decision on April 3, 2002, 26 days after receiving the submission on March 8, 2002.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.3450.
| 510(k) Number | K020767 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 08, 2002 |
| Decision Date | April 03, 2002 |
| Days to Decision | 26 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Statement |
| Product Code | DSY — Prosthesis, Vascular Graft, Of 6mm And Greater Diameter |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.3450 |