510(k) K102900 ยท LGZ Warmer, Thermal, Infusion Fluid
HEITER 3000 HYPERTHERMIC PERFUSION SYSTEM
| Applicant | Hei, Inc., Boulder CO, US |
| Decision | Substantially Equivalent, Mar 21, 2012 |
| Received | Sep 30, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K102900
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 4, 2021 | Eight Medical International BV Recirculator 8.0s Disposable Lavage Kit (product code number 8100) , GTIN: 08719992086016. Hyperthermic Perfusion System intended to raise the temperature of the thoracic or peritoneal cavity to a t Terminated |
LGZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.