Submission Details
| 510(k) Number | K201320 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | May 18, 2020 |
| Decision Date | November 03, 2021 |
| Days to Decision | 534 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
Cleared
Traditional
Quantum PureFlow Centrifugal Blood Pump CP22 with Integrated Sensor
Nov 2021
Decision
534d
Days
Class 2
Risk
About This 510(k) Submission
K201320 is an FDA 510(k) clearance for the Quantum PureFlow Centrifugal Blood Pump CP22 with Integrated Sensor, 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 November 3, 2021, 534 days after receiving the submission on May 18, 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
Similar Devices — KFM Pump, Blood, Cardiopulmonary Bypass, Non-roller Type
All 83
K251762 · Spectrum Medical S.R.L.
· Aug 2025
K250326 · Spectrum Medical S.R.L.
· Jun 2025
K233091 · Qura S.R.L
· Oct 2023
K232132 · Cardiacassist, Inc.
· Aug 2023
K220842 · Qura S.R.L
· May 2023
K200091 · Terumo Cardiovascular Systems Corporation
· Nov 2021
More from Qura S.R.L
View all
K231982
· DTZ · Sep 2024
K231773
· DTZ · Nov 2023
K233091
· KFM · Oct 2023
K220842
· KFM · May 2023
K221353
· DWF · Aug 2022