Quantum PureFlow Centrifugal Blood Pump CP22 with Integrated Sensor— 510(k) K201320
Substantially EquivalentQura S.R.L
FDA 510(k) clearance K201320 for Quantum PureFlow Centrifugal Blood Pump CP22 with Integrated Sensor, Substantially Equivalent on 2021-11-03. Applicant: Qura S.R.L. Device class: 2.
Clearance details
- Applicant
- Qura S.R.L
- Product code
- Code KFM
- Device class
- Class 2
- Regulation
- 21 CFR 870.4360
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mirandola, IT
Recent devices under product code KFM
view all- K251762 — Quantum Perfusion Centrifugal Blood Pump CP20NG with Integrated Sensors (CP20V-NG)
- K250326 — Quantum Perfusion Centrifugal Blood Pump CP22NG with Integrated Sensors (CP22V-NG)
- K233091 — Quantum Perfusion Centrifugal Blood Pump CP37 with Integrated Sensors (CP37V-VT) +1 more
- K232132 — LifeSPARC System
- K220842 — Quantum Perfusion Centrifugal Blood Pump CP22 with Integrated Sensors, Quantum Perfusion Centrifugal Blood Pump CP20 with Integrated Sensors
More clearances from Qura S.R.L
view all- K231982 — Quantum Perfusion Blood Oxygenator VT75-E1, Quantum Perfusion Blood Oxygenator VT75-E2
- 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
- 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
- K213540 — Quantum SuperPAC Tubing Set, Quantum SuperPAC Cardioplegia Set
- K220110 — Quantum PureFlow Standard Heat Exchanger and Quantum PureFlow Cardioplegia Heat Exchanger
Adverse events under product code KFM
product code KFM- Death
- 109
- Injury
- 241
- Malfunction
- 1,779
- Total
- 2,129
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K201320
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K201320.
Data sourced from openFDA. This site is unofficial and independent of the FDA.