Quantum PureFlow Standard Heat Exchangers (HX11W-S2, HX11W-S1M and HX11W-S2M)— 510(k) K223879
Substantially EquivalentQuara S.R.L.
FDA 510(k) clearance K223879 for Quantum PureFlow Standard Heat Exchangers (HX11W-S2, HX11W-S1M and HX11W-S2M), Substantially Equivalent on 2023-04-13. Applicant: Quara S.R.L.. Device class: 2.
Clearance details
- Applicant
- Quara S.R.L.
- Product code
- Code DTR
- Device class
- Class 2
- Regulation
- 21 CFR 870.4240
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Mirandola, IT
Recent devices under product code DTR
view all- K252541 — Quantum PureFlow Standard Heat Exchanger Medium Flow 1/4 W
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- K220110 — Quantum PureFlow Standard Heat Exchanger and Quantum PureFlow Cardioplegia Heat Exchanger
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.