K090987 is an FDA 510(k) clearance for the VASCUTEK BRANCHED GELWEAVE. 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. (Inchinnan, Renfrewshire, GB). The FDA issued a Cleared decision on June 19, 2009, 73 days after receiving the submission on April 7, 2009.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.3450.
| 510(k) Number | K090987 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 07, 2009 |
| Decision Date | June 19, 2009 |
| Days to Decision | 73 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 |