DeviceClearance

K241206

Substantially Equivalent

Quantum Perfusion Hybrid System

Applicant
Spectrum Medical S.R.L.
Product code
DTN
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Mirandola, IT
Download summary PDF View on FDA.gov ↗

Adverse events under product code DTN

product code DTN
Death
3
Total
3

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.