510(k) K071778 ยท DSY Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
HERO VASCULAR ACCESS DEVICE
| Applicant | Graftcath, Inc., Eden Prarie MN, US |
| Decision | Substantially Equivalent, Jan 30, 2008 |
| Received | Jul 2, 2007 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K071778
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.