510(k) K073693 ยท KDN System, Perfusion, Kidney
COSTORSOL
| Applicant | Preservation Solutions, Inc., Denver CO, US |
| Decision | Substantially Equivalent, Jul 3, 2008 |
| Received | Dec 31, 2007 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K073693
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 26, 2018 | Preservation Solutions, Inc. Cold Storage Solution, 2L, labeled as Waters IGL Cold Storage Solution, Catalog No. CSS/2000/US; and, Belzer UW Cold Storage Solution, Catalog No. BUW_002.
Intended for the hypothermic flushing and Terminated |
KDN | None listed |
| Nov 22, 2010 | Preservation Solutions Inc Belzer UW Cold Storage Solution, 1000 mL. Sterile and non-pyrogenic. Formulated for flushing and cold storage of kidney, liver and pancreas organs. Manufactured by: Preservation Solutions, Inc., El Terminated |
KDN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.