510(k) K220110
K220110 is an FDA 510(k) premarket notification submitted by Qura S.R.L for the device "Quantum PureFlow Standard Heat Exchanger and Quantum PureFlow Cardioplegia Heat Exchanger". The FDA issued a decision of Substantially Equivalent on May 6, 2022. The device falls under product code DTR (Heat-Exchanger, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4240. Qura S.R.L has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 6, 2022
- Date Received
- January 13, 2022
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Heat-Exchanger, Cardiopulmonary Bypass
- Device Class
- Class II
- Regulation Number
- 870.4240
- Review Panel
- CV
- Submission Type