510(k) K152208 ยท LGZ Warmer, Thermal, Infusion Fluid
The Belmont Hyperthermia Pump
| Applicant | Belmont Instrument Corporation, Billerica MA, US |
| Decision | Substantially Equivalent, Sep 2, 2015 |
| Received | Aug 7, 2015 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K152208
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 25, 2025 | Belmont Instrument LLC Hyperthermia Pump Procedure Kit. Model Number: 902-00045.
Sterile, single-use, disposable set used with the Hyperthermia Pump. The Hyperthermia Procedure kit (P/N 902-00045) consists of 4.4 Liter Open, Classified |
LGZ | None listed |
| Apr 25, 2025 | Belmont Instrument LLC Straight Inflow/Outflow Patient Line Kit. Model Number: 902-00037.
Sterile, single-use, disposable set used with the Hyperthermia Pump. The Straight Inflow/Outflow Patient Line Kit (P/N 902-00037) Open, Classified |
LGZ | None listed |
| Apr 25, 2025 | Belmont Instrument LLC Straight Inflow/Bifurcated Outflow Line Kit. Model Number: 902-00038.
Sterile, single-use, disposable set used with the Hyperthermia Pump. The Straight Inflow/Outflow Patient Line Kit (P/N 902-000 Open, Classified |
LGZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.