FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇹 Italy
Quantum PureFlow Centrifugal Blood Pump CP22 with Integrated Sensor
K Number: K201320
·
Decision Nov 3, 2021
Classifications
1
FEI Numbers
35
Registration Numbers
35
Same Product Code
83
Applicant Total
15
Review Days
534
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Basic Information
- Device Name
- Quantum PureFlow Centrifugal Blood Pump CP22 with Integrated Sensor
- K Number
- K201320
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.4360
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Qura S.R.L
- Date Received
- May 18, 2020
- Decision Date
- November 3, 2021
- Product Code
- KFM
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| KFM | Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type | FDA class 2 | Cardiovascular |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KFM), ordered by most recent decision date.
Quantum Perfusion Centrifugal Blood Pump CP20NG with Integrated Sensors (CP20V-NG)
FDA 510(k)
FDA Class 2
·Cardiovascular
Quantum Perfusion Centrifugal Blood Pump CP22NG with Integrated Sensors (CP22V-NG)
FDA 510(k)
FDA Class 2
·Cardiovascular
Quantum Perfusion Centrifugal Blood Pump CP37 with Integrated Sensors (CP37V-VT); Quantum Perfusion Centrifugal Blood Pump CP22 with Integrated Sensors (CP22V-VT)
FDA 510(k)
FDA Class 2
·Cardiovascular
LifeSPARC System
FDA 510(k)
FDA Class 2
·Cardiovascular
Quantum Perfusion Centrifugal Blood Pump CP22 with Integrated Sensors, Quantum Perfusion Centrifugal Blood Pump CP20 with Integrated Sensors
FDA 510(k)
FDA Class 2
·Cardiovascular
Capiox iCP Centrifugal Pump
FDA 510(k)
FDA Class 2
·Cardiovascular
Other Clearances by Qura S.R.L
| K Number | Device Name | ||
|---|---|---|---|
| K231982 | Quantum Perfusion Blood Oxygenator VT75-E1, Quantum Perfusion Blood Oxygenator VT75-E2 | Sep 12, 2024 | Substantially Equivalent |
| K231773 | Quantum Perfusion Blood Oxygenator with Integrated AF and Sensor VT75-C1U, Quantum Perfusion Blood Oxygenator with Integrated AF VT75-C2U, Quantum Perfusion Blood Oxygenator with Integrated AF and Sensor VT200-C1U, Quantum Perfusion Blood Oxygenator with Integrated AF VT200-C2U, Quantum Perfusion Blood Oxygenator with Integrated AF and Sensor VT160-C1U | Nov 8, 2023 | Substantially Equivalent |
| K233091 | Quantum Perfusion Centrifugal Blood Pump CP37 with Integrated Sensors (CP37V-VT); Quantum Perfusion Centrifugal Blood Pump CP22 with Integrated Sensors (CP22V-VT) | Oct 26, 2023 | Substantially Equivalent |
| K220842 | Quantum Perfusion Centrifugal Blood Pump CP22 with Integrated Sensors, Quantum Perfusion Centrifugal Blood Pump CP20 with Integrated Sensors | May 19, 2023 | Substantially Equivalent |
| K221353 | Quantum Perfusion Dual Lumen Cannula 31F, Quantum Perfusion Dual Lumen Cannula 27F, Quantum Perfusion Dual Lumen Cannula 24F, Quantum Perfusion Dual Lumen Cannula 29F, Quantum Perfusion Dual Lumen Cannula 24F-V1, Quantum Perfusion Dual Lumen Cannula 27F-V1, Quantum Perfusion Dual Lumen Cannula 29F-V1, Quantum Perfusion Dual Lumen Cannula 27F-VS, Quantum Perfusion Dual Lumen Cannula 31F-VS | Aug 18, 2022 | Substantially Equivalent |
| K213540 | Quantum SuperPAC Tubing Set, Quantum SuperPAC Cardioplegia Set | May 20, 2022 | Substantially Equivalent |
| K220110 | Quantum PureFlow Standard Heat Exchanger and Quantum PureFlow Cardioplegia Heat Exchanger | May 6, 2022 | Substantially Equivalent |
| K212341 | Quantum Perfusion Blood Oxygenator with Integrated AF and Sensor VT200-C1U, Quantum Perfusion Blood Oxygenator with Integrated AF VT200-C2U, Quantum Perfusion Blood Oxygenator with Integrated AF and Sensor VT160-C1U,Quantum Perfusion Blood Oxygenator with Integrated AF VT160-C2U | Jan 28, 2022 | Substantially Equivalent |
| K212688 | Quantum PureFlow Standard Heat Exchanger, Quantum PureFlow Cardioplegia Heat Exchanger | Jan 10, 2022 | Substantially Equivalent |
| K203424 | Quantum Perfusion Blood Oxygenator ECC VT200-E1, Quantum Perfusion Blood Oxygenator ECC VT200-E2, Quantum Perfusion Blood Oxygenator ECC VT160-E1, Quantum Perfusion Blood Oxygenator ECC VT160-E2 | Dec 17, 2021 | Substantially Equivalent |