510(k) K002813 ยท FIE Needle, Fistula
NIPRO SAFETOUCH SAFETY FISTULA NEEDLE
| Applicant | Nipro Medical Corp., Weston FL, US |
| Decision | Substantially Equivalent, Nov 21, 2000 |
| Received | Sep 8, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K002813
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 21, 2003 | Nipro Corp The following brand name labeled products are under recall (all
catalog numbers and all lot numbers under recall):
NIPRO SafeTouch Safety Fistula Needle, Baxter Safety AV Fistula
Set and EXEL Secure Terminated |
FIE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.