510(k) K191006 ยท KDN System, Perfusion, Kidney
EasiSlush
| Applicant | Bridge TO Life, Ltd., Columbia SC, US |
| Decision | Substantially Equivalent, Sep 24, 2019 |
| Received | Apr 16, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K191006
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 22, 2025 | Bridge to Life Ltd Bridge to Life EasiSlush, (Sodium Chloride Solution for Sterile Slush Preparation) (0.9% Sodium Chloride Irrigation, USP), Part Number REF BTLE-1250 Open, Classified |
KDN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.