510(k) K021362 ยท KDN System, Perfusion, Kidney
LIFEPORT, KIDNEY PERFUSION TRANSPORTER (KTR)
| Applicant | Organ Recovery Systems, Inc., Charleston SC, US |
| Decision | Substantially Equivalent, Jul 31, 2003 |
| Received | Apr 30, 2002 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K021362
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 30, 2020 | Organ Recovery Systems, Inc. LKT200 Perfusion Circuit, part of Lifeport Kidney Perfusion Transporter KTR - Product Usage: The circuit is an accessory to LifePort Kidney Perfusion Transporter (KTR) Isolated kidney perfusion and tr Terminated |
KDN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.