Submission Details
| 510(k) Number | K202169 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | August 03, 2020 |
| Decision Date | September 02, 2020 |
| Days to Decision | 30 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
Cleared
Special
Quantum PureFlow Centrifugal Blood Pump CP37, Quantum PureFlow Centrifugal Blood Pump CP22
Sep 2020
Decision
30d
Days
Class 2
Risk
About This 510(k) Submission
K202169 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 September 2, 2020, 30 days after receiving the submission on August 3, 2020. 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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