510(k) K140205 ยท CAC Apparatus, Autotransfusion
PLEUR-EVAC SAHARA PLUS CONTINUOUS REINFUSION AND AUTOTRANSFUSION SYSTEM
| Applicant | Teleflexmedical, Inc., Research Triangle Park NC, US |
| Decision | Substantially Equivalent, Oct 23, 2014 |
| Received | Jan 27, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K140205
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 30, 2016 | Teleflex Medical Pleur-evac Chest Drainage System, Dry Suction/Dry Seal Control, REF A-6000-08LF, Rx Only, Teleflex Medical.
Product Usage:
Pleur-Evacs are sterile, single-use, chest drainage systems intended for pos Terminated |
CAC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.