Quantum Perfusion Centrifugal Blood Pump CP22NG with Integrated Sensors (CP22V-NG)— 510(k) K250326
Substantially EquivalentSpectrum Medical S.R.L.
FDA 510(k) clearance K250326 for Quantum Perfusion Centrifugal Blood Pump CP22NG with Integrated Sensors (CP22V-NG), Substantially Equivalent on 2025-06-24. Applicant: Spectrum Medical S.R.L.. Device class: 2.
Clearance details
- Applicant
- Spectrum Medical S.R.L.
- Product code
- Code KFM
- Device class
- Class 2
- Regulation
- 21 CFR 870.4360
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mirandola, IT
Recent devices under product code KFM
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- K220842 — Quantum Perfusion Centrifugal Blood Pump CP22 with Integrated Sensors, Quantum Perfusion Centrifugal Blood Pump CP20 with Integrated Sensors
- K200091 — Capiox iCP Centrifugal Pump
More clearances from Spectrum Medical S.R.L.
view allAdverse events under product code KFM
product code KFM- Death
- 109
- Injury
- 241
- Malfunction
- 1,779
- Total
- 2,129
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.