510(k) K091656 ยท KDL Set, Perfusion, Kidney, Disposable
SPS-1TM STATIC PRESERVATION SOLUTION, MODELS SPS-1-500 ML, SPS 1-1L, SPS-1-2L
| Applicant | Organ Recovery Systems, Inc., Des Plaines IL, US |
| Decision | Substantially Equivalent, Mar 11, 2010 |
| Received | Jun 9, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K091656
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 14, 2016 | Organ Recovery Systems, Inc. SPS-1, Static Preservation Solution [1 or 2 liter bags], Sterile; Organ Recovery Systems, One Pierce Place, Itasca, IL 60143 Terminated |
KDL | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.