510(k) K112628 ยท FJK Set, Tubing, Blood, With And Without Anti-Regurgitation Valve
NIPRO BLOOD TUBING SET WITH TRANSDUCER PROTECTOR AND PRIMING SET
| Applicant | Nipro Medical Corporation, Miami FL, US |
| Decision | Substantially Equivalent, Sep 28, 2012 |
| Received | Sep 9, 2011 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K112628
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 8, 2016 | Nipro Medical Corporation NIPRO SET / SLIMLINE BLOOD TUBING SET for Hemodialysis with Transducer Protectors and Priming Set
A disposable bloodline intended to provide extracorporeal access to the patient's blood during Hemod Terminated |
FJK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.