K914116 is an FDA 510(k) clearance for the PLASMA TFE SYNTHETIC ARTERY-CLARIFICATION. 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 November 27, 1991, 83 days after receiving the submission on September 5, 1991.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.3450.
| 510(k) Number | K914116 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 05, 1991 |
| Decision Date | November 27, 1991 |
| Days to Decision | 83 days |
| Submission Type | Traditional |
| 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 |