510(k) K000714 ยท FMI Needle, Hypodermic, Single Lumen
VACUFLOW+SAFE BLOOD COLLECTION SET AND VACUFLOW+SAFE WITH HOLDER BLOOD COLLECTION SET
| Applicant | Med-Pro Technologies, Inc., Appollo Beach FL, US |
| Decision | Substantially Equivalent, Dec 21, 2000 |
| Received | Mar 2, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K000714
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 22, 2016 | Global Healthcare Inc MED 5223 - VacuFlow Safe, Multi-Sample Blood Collection Set With Luer Adapter Tube 12", Sterile, Rx only, Distributed by Tanner Scientific, Sarasota, FGL 34243 Made in China. Terminated |
FMI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.