510(k) K983003 ยท KRA Catheter, Continuous Flush
1 MASS TRANSIT INFUSION CATHETER, 1 VARIOUS
| Applicant | Cordis Neurovascular, Inc., Miami Lake FL, US |
| Decision | Substantially Equivalent, Sep 17, 1998 |
| Received | Aug 28, 1998 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K983003
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 30, 2008 | Cordis Corporation MassTRANSIT Infusion Catheter Kit, 605-731K & 605-780K, Cordis Neurovascular
Intended to be used as a mechanism for the infusion of various diagnostic, embolic, and therapeutic agents into the Neurov Terminated |
KRA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.