510(k) K971192 ยท DSY Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
IMPRA EPTFE ARTERIOVENOUS CUFFED GRAFT
| Applicant | Impra, Inc., Tempe AZ, US |
| Decision | Substantially Equivalent - Subject to Tracking Reg., Apr 15, 1997 |
| Received | Mar 31, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K971192
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.