Submission Details
| 510(k) Number | K192850 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | October 03, 2019 |
| Decision Date | April 13, 2020 |
| Days to Decision | 193 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
Cleared
Traditional
Quantum PureFlow Centrifugal Blood Pump CP37, Quantum PureFlow Centrifugal Blood Pump CP22
Apr 2020
Decision
193d
Days
Class 2
Risk
About This 510(k) Submission
K192850 is an FDA 510(k) clearance for the Quantum PureFlow Centrifugal Blood Pump CP37, Quantum PureFlow Centrifugal Blood Pump CP22, a Pump, Blood, Cardiopulmonary Bypass, Non-roller Type (Class II — Special Controls, product code KFM), submitted by Qura S.R.L (Mirandola, IT). The FDA issued a Cleared decision on April 13, 2020, 193 days after receiving the submission on October 3, 2019. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4360.
Device Classification
| Product Code | KFM — Pump, Blood, Cardiopulmonary Bypass, Non-roller Type |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 870.4360 |
Manufacturer
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