510(k) K091491 ยท DSY Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
HERO VASCULAR ACCESS DEVICE
| Applicant | Hemosphere, Inc., Eden Prarie MN, US |
| Decision | Substantially Equivalent, Jul 31, 2009 |
| Received | May 20, 2009 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K091491
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.