Submission Details
| 510(k) Number | K212688 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | August 25, 2021 |
| Decision Date | January 10, 2022 |
| Days to Decision | 138 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
Cleared
Traditional
Quantum PureFlow Standard Heat Exchanger, Quantum PureFlow Cardioplegia Heat Exchanger
Jan 2022
Decision
138d
Days
Class 2
Risk
About This 510(k) Submission
K212688 is an FDA 510(k) clearance for the Quantum PureFlow Standard Heat Exchanger, Quantum PureFlow Cardioplegia Heat Exchanger, a Heat-exchanger, Cardiopulmonary Bypass (Class II — Special Controls, product code DTR), submitted by Qura S.R.L (Mirandola, IT). The FDA issued a Cleared decision on January 10, 2022, 138 days after receiving the submission on August 25, 2021. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4240.
Device Classification
| Product Code | DTR — Heat-exchanger, Cardiopulmonary Bypass |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 870.4240 |
Manufacturer
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