K983769 is an FDA 510(k) clearance for the DISTAFLO BYPASS GRAFT. This device is classified as a Prosthesis, Vascular Graft, Of Less Then 6mm Diameter (Class II - Special Controls, product code DYF).
Submitted by Impra, Inc. (Tempe, US). The FDA issued a Cleared decision on December 15, 1998, 50 days after receiving the submission on October 26, 1998.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.3450.
| 510(k) Number | K983769 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 26, 1998 |
| Decision Date | December 15, 1998 |
| Days to Decision | 50 days |
| Submission Type | Abbreviated |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DYF — Prosthesis, Vascular Graft, Of Less Then 6mm Diameter |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.3450 |