K893459 is an FDA 510(k) clearance for the PLASMA TFE VASCULAR PROSTHESIS (ALTER. PACKAGE). This device is classified as a Prosthesis, Vascular Graft, Of 6mm And Greater Diameter (Class II - Special Controls, product code DSY).
Submitted by Medtronic Vascular (Minneapolis, US). The FDA issued a Cleared decision on September 20, 1989, 140 days after receiving the submission on May 3, 1989.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.3450.
| 510(k) Number | K893459 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 03, 1989 |
| Decision Date | September 20, 1989 |
| Days to Decision | 140 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | — |
| Product Code | DSY — Prosthesis, Vascular Graft, Of 6mm And Greater Diameter |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.3450 |