510(k) K162803 ยท DSY Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
Gelseal Vascular Grafts, Gelsoft Vascular Grafts, Gelsoft Plus Vascular Grafts
| Applicant | Vascutek, Ltd., Inchinnan, GB |
| Decision | Substantially Equivalent, Jul 14, 2017 |
| Received | Oct 5, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K162803
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.