Quantum PureFlow Standard Heat Exchanger and Quantum PureFlow Cardioplegia Heat Exchanger— 510(k) K220110
Substantially EquivalentQura S.R.L
FDA 510(k) clearance K220110 for Quantum PureFlow Standard Heat Exchanger and Quantum PureFlow Cardioplegia Heat Exchanger, Substantially Equivalent on 2022-05-06. Applicant: Qura S.R.L.
Clearance details
- Applicant
- Qura S.R.L
- Product code
- Code DTR
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- 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, 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.