510(k) K991027 ยท DSY Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
BI-DIRECTIONAL TUNNELER
| Applicant | Impra, Inc., Tempe AZ, US |
| Decision | Substantially Equivalent, Apr 22, 1999 |
| Received | Mar 29, 1999 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K991027
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.