K233783 is an FDA 510(k) clearance for the exGraft ePTFE Vascular Grafts, exGraft Carbon ePTFE Vascular Grafts. This device is classified as a Prosthesis, Vascular Graft, Of 6mm And Greater Diameter (Class II - Special Controls, product code DSY).
Submitted by Peca Labs, Inc. (Pittsburgh, US). The FDA issued a Cleared decision on January 17, 2024, 51 days after receiving the submission on November 27, 2023.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.3450.
| 510(k) Number | K233783 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 27, 2023 |
| Decision Date | January 17, 2024 |
| Days to Decision | 51 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DSY - Prosthesis, Vascular Graft, Of 6mm And Greater Diameter |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.3450 |