Submission Details
| 510(k) Number | K223879 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | December 27, 2022 |
| Decision Date | April 13, 2023 |
| Days to Decision | 107 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
Cleared
Special
Quantum PureFlow Standard Heat Exchangers (HX11W-S2, HX11W-S1M and HX11W-S2M)
Apr 2023
Decision
107d
Days
Class 2
Risk
About This 510(k) Submission
K223879 is an FDA 510(k) clearance for the Quantum PureFlow Standard Heat Exchangers (HX11W-S2, HX11W-S1M and HX11W-S2M), a Heat-exchanger, Cardiopulmonary Bypass (Class II — Special Controls, product code DTR), submitted by Quara S.R.L. (Mirandola, IT). The FDA issued a Cleared decision on April 13, 2023, 107 days after receiving the submission on December 27, 2022. 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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