510(k) K934377 ยท FGE Stents, Drains And Dilators For The Biliary Ducts
INNERDYNE REMOTE RADIALLY EXPANDING DILATOR REMOTE R.E.D.
| Applicant | Interventional Thermodynamics, Inc., Mountain View CA, US |
| Decision | Substantially Equivalent, Feb 7, 1994 |
| Received | Sep 9, 1993 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K934377
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.