K000504 is an FDA 510(k) clearance for the ADVANTA SUPER SOFT GRAFT. This device is classified as a Prosthesis, Vascular Graft, Of Less Then 6mm Diameter (Class II - Special Controls, product code DYF).
Submitted by Atrium Medical Corp. (Hudson, US). The FDA issued a Cleared decision on March 1, 2000, 15 days after receiving the submission on February 15, 2000.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.3450.
| 510(k) Number | K000504 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 15, 2000 |
| Decision Date | March 01, 2000 |
| Days to Decision | 15 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Statement |
| Product Code | DYF — Prosthesis, Vascular Graft, Of Less Then 6mm Diameter |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.3450 |