510(k) K241248— Quantum Perfusion Dual Lumen Cannula 31F-V1 (DL31F-V1)

Substantially Equivalent

Spectrum Medical S.R.L.

Clearance details

Applicant: Spectrum Medical S.R.L.
Product code: Code DWF
Advisory panel: Cardiovascular
Date received: 2024-05-03
Decision date: 2024-05-31
Decision: Substantially Equivalent
Clearance type: Special
Location: Mirandola, IT

Adverse events under product code DWF

product code DWF

Death: 106
Injury: 386
Malfunction: 2,323
Total: 2,815

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.