K910866 is an FDA 510(k) clearance for the VASCUSOFT (VP1200K) KNITTED VASCULAR PROSTHESIS. 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. (Pa49rr Scotland, GB). The FDA issued a Cleared decision on April 1, 1991, 31 days after receiving the submission on March 1, 1991.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.3450.
| 510(k) Number | K910866 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 01, 1991 |
| Decision Date | April 01, 1991 |
| Days to Decision | 31 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 |