510(k) K031583 ยท DYB Introducer, Catheter
MODIFICATION TO IVS INTRODUCER SET, MODEL 1003
| Applicant | Integrated Vascular Systems, Inc., Sunnyvale CA, US |
| Decision | Substantially Equivalent, Jun 16, 2003 |
| Received | May 21, 2003 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K031583
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.