Quantum Heater-Cooler— 510(k) K212657
Substantially EquivalentSpectrum Medical , Ltd.
FDA 510(k) clearance K212657 for Quantum Heater-Cooler, Substantially Equivalent on 2022-05-06. Applicant: Spectrum Medical , Ltd.. Device class: 2.
Clearance details
- Applicant
- Spectrum Medical , Ltd.
- Product code
- Code DWC
- Device class
- Class 2
- Regulation
- 21 CFR 870.4250
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Gloucester, GB
Recent devices under product code DWC
view allMore clearances from Spectrum Medical , Ltd.
view all- K240908 — Quantum Micro-Cardioplegia Delivery System; Quantum Micro-Cardioplegia Delivery Module (QMCDM)
- K210669 — Quantum Mini Ventilation Module
- K202733 — Quantum Ventilation Module
- K202557 — Quantum Workstation 12 Elite
- K192838 — Quantumn Centrifugal Drive- High Pressure, Quantum Centrifugal Drive- Medium Pressure
Adverse events under product code DWC
product code DWC- Death
- 124
- Injury
- 233
- Malfunction
- 3,727
- Total
- 4,084
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.