510(k) K212688— Quantum PureFlow Standard Heat Exchanger, Quantum PureFlow Cardioplegia Heat Exchanger

Substantially Equivalent

Qura S.R.L

Clearance details

Applicant: Qura S.R.L
Product code: Code DTR
Advisory panel: Cardiovascular
Date received: 2021-08-25
Decision date: 2022-01-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mirandola, IT

Adverse events under product code DTR

product code DTR

Other: 1
Total: 1

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.