Quantum Perfusion Hybrid System— 510(k) K241206

Substantially Equivalent

Spectrum Medical S.R.L.

FDA 510(k) clearance K241206 for Quantum Perfusion Hybrid System, Substantially Equivalent on 2024-07-18. Applicant: Spectrum Medical S.R.L..

Clearance details

Applicant: Spectrum Medical S.R.L.
Product code: Code DTN
Advisory panel: Cardiovascular
Date received: 2024-04-30
Decision date: 2024-07-18
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, 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.