510(k) K910734 ยท FIE Needle, Fistula
MEDISYSTEMS HEMODIALYSIS FISTULA SET
| Applicant | Medisystems Corp., San Francisco CA, US |
| Decision | Substantially Equivalent, Jun 20, 1991 |
| Received | Feb 21, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K910734
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 24, 2013 | Medisystems a NX Stage Company Medisystems 17 Gauge x 1" inch AV Fistula Needle
Product Code: D9-2007MGLB
Product Usage:
Medisystems AVF with MasterGuard anti-stick needle protector is indicated for use as a vascular access device Terminated |
FIE | None listed |
| Feb 29, 2012 | Medisystems Corp Medisystems (a Nxstage Company) Hemodialysis Fistula Needle Set with MasterGuard Ant-Stick Needle Protector 15 GA x 1"
Ref. Number: D9-2007MG.
Medisystems AVF with MasterGuard anti-stick needle prote Terminated |
FIE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.