510(k) K134019 ยท FIE Needle, Fistula
MEDISYSTEMS ONESITE DUAL LUMEN NEEDLE WITH MASTERGUARD ANTI-STICK NEEDLE PROTECTOR, MEDISYSTEMS ONESITE DUAL LUMEN BUTTO
| Applicant | Nxstage Medical, Inc., Lawrence MA, US |
| Decision | Substantially Equivalent, Sep 11, 2014 |
| Received | Dec 30, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K134019
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.