K241070 is an FDA 510(k) clearance for the Gelsoft™ Plus Vascular Prostheses. This device is classified as a Prosthesis, Vascular Graft, Of 6mm And Greater Diameter (Class II - Special Controls, product code DSY).
Submitted by Vascutek, Ltd. (Renfrewshire, GB). The FDA issued a Cleared decision on November 15, 2024, 210 days after receiving the submission on April 19, 2024.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.3450.
| 510(k) Number | K241070 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 19, 2024 |
| Decision Date | November 15, 2024 |
| Days to Decision | 210 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 |