510(k) K990803 ยท FIE Needle, Fistula
MEDISYSTEMS BUTTONHOLE NEEDLE SETS
| Applicant | Medisystems Corp., Washington DC, US |
| Decision | Substantially Equivalent, Jan 6, 2000 |
| Received | Mar 10, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K990803
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 24, 2013 | Medisystems a NX Stage Company Medisystems 15 Gauge x 3/5 inch Buttonhole Needle Set
Product Code: BH-2035PE
Product Usage:
Medisystems Buttonhole Needle Sets are indicated for use as an access device for dialysis and pheresis pro Terminated |
FIE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.