510(k) K111702 ยท LKN Separator, Automated, Blood Cell And Plasma, Therapeutic
AMICUS SEPARATOR SYSTEM- USE IN THERAPEUTIC PLASMA EXCHANGE AND FILTER SET FOR AMICUS TPE
| Applicant | Fenwal, Inc., Lake Zurich IL, US |
| Decision | Substantially Equivalent, Mar 22, 2012 |
| Received | Jun 17, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K111702
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 8, 2013 | Fenwal Inc AMICUS Exchange Kit;
Product Usage:
This kit is designed for use with the AMICUS separator for the Therapeutic Plasma Exchange (TPE) procedure. Sterilized by irradiation. Sterile fluid path. Non-pyr Terminated |
LKN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.