510(k) K980578 ยท DYB Introducer, Catheter
INNERDYNE RADIALLY EXPANDING VASCULAR ACCESS SYSTEM (HEPARIN COATED)
| Applicant | Innerdyne, Inc., Salt Lake City UT, US |
| Decision | Substantially Equivalent, Sep 11, 1998 |
| Received | Feb 17, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K980578
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.