510(k) K133807 ยท FLD Apparatus, Hemoperfusion, Sorbent
MARS MONITOR ITC US, MARS TREATMENT KIT TYPE 1116/1 - X-MARS US, PRISMAFLEX CONTROL UNIT
| Applicant | Gambro Renal Products, Inc., Lakewood CO, US |
| Decision | Substantially Equivalent, Mar 26, 2014 |
| Received | Dec 16, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K133807
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 21, 2017 | Baxter Healthcare Corporation MARS Treatment Kit, Use only with MARS(R) Monitor 1TC, GAMBRO, Product Code 800541 Terminated |
FLD | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.