Quantumn Centrifugal Drive- High Pressure, Quantum Centrifugal Drive- Medium Pressure— 510(k) K192838

Substantially Equivalent

Spectrum Medical , Ltd.

FDA 510(k) clearance K192838 for Quantumn Centrifugal Drive- High Pressure, Quantum Centrifugal Drive- Medium Pressure, Substantially Equivalent on 2020-04-13. Applicant: Spectrum Medical , Ltd..

Clearance details

Applicant: Spectrum Medical , Ltd.
Product code: Code DWA
Advisory panel: Cardiovascular
Date received: 2019-10-03
Decision date: 2020-04-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gloucester, GB

Download summary PDF View on FDA.gov ↗

Adverse events under product code DWA

product code DWA

Death: 15
Malfunction: 1,654
Total: 1,669

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.