The Belmont Hyperthermia Pump
FDA 510(k) clearance K152208 · decided 2015-09-02
Clearance details
- K-number
- K152208
- Device name
- The Belmont Hyperthermia Pump
- Applicant
- Belmont Instrument Corporation
- Decision
- Substantially Equivalent
- Date received
- 2015-08-07
- Decision date
- 2015-09-02
- Days to decision
- 26 days
- Clearance type
- Special
- Product code
- LGZ
- Device class
- 2
- Regulation number
- 880.5725
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Billerica, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Hyperthermia Pump Procedure Kit. Model Number: 902-00045. Sterile, single-use, disposable recall (Z-1674-2025) | Belmont Instrument LLC | 2025-04-25 |
| Straight Inflow/Outflow Patient Line Kit. Model Number: 902-00037. Sterile, single-use, di recall (Z-1675-2025) | Belmont Instrument LLC | 2025-04-25 |
| Straight Inflow/Bifurcated Outflow Line Kit. Model Number: 902-00038. Sterile, single-use, recall (Z-1676-2025) | Belmont Instrument LLC | 2025-04-25 |