FDA 510(k)

Quantum Perfusion Centrifugal Blood Pump CP20NG with Integrated Sensors (CP20V-NG)

N.º K: K251762 · 2025-08-04

Fecha de decisión2025-08-04

Código de productoKFM

Comité asesorCV

DecisiónSubstantially Equivalent

Resumen del dispositivo

Quantum Perfusion Centrifugal Blood Pump CP20NG with Integrated Sensors (CP20V-NG) is the device name listed in this FDA 510(k) record. The listed applicant is Spectrum Medical S.R.L.. It received FDA 510(k) clearance on 2025-08-04 under 510(k) number K251762. The device is classified under product code KFM. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Quantum Perfusion Centrifugal Blood Pump CP20NG with Integrated Sensors (CP20V-NG)?

Quantum Perfusion Centrifugal Blood Pump CP20NG with Integrated Sensors (CP20V-NG) is a medical device that received FDA 510(k) clearance on 2025-08-04. The listed applicant is Spectrum Medical S.R.L.. The 510(k) number is K251762.

When did Quantum Perfusion Centrifugal Blood Pump CP20NG with Integrated Sensors (CP20V-NG) receive FDA 510(k) clearance?

Quantum Perfusion Centrifugal Blood Pump CP20NG with Integrated Sensors (CP20V-NG) received FDA 510(k) clearance on 2025-08-04, under 510(k) number K251762.

Who is the listed applicant for Quantum Perfusion Centrifugal Blood Pump CP20NG with Integrated Sensors (CP20V-NG)?

The FDA 510(k) record lists Spectrum Medical S.R.L. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Quantum Perfusion Centrifugal Blood Pump CP20NG with Integrated Sensors (CP20V-NG)?

The FDA product code for Quantum Perfusion Centrifugal Blood Pump CP20NG with Integrated Sensors (CP20V-NG) is KFM.

Ensayos clínicos relacionados

Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Otros registros que enlistan a Spectrum Medical S.R.L. como solicitante

K240934Quantum Perfusion Blood Oxygenator ECC VT160-E3 (VT160-E3); Quantum Perfusion Blood Oxygenator ECC VT200-E3 (VT200-E3); Quantum Perfusion Blood Oxygenator VT75- E3 (VT75- E3);K252541Quantum PureFlow Standard Heat Exchanger Medium Flow 1/4 W K250326Quantum Perfusion Centrifugal Blood Pump CP22NG with Integrated Sensors (CP22V-NG)K241206Quantum Perfusion Hybrid System K241248Quantum Perfusion Dual Lumen Cannula 31F-V1 (DL31F-V1)

Dispositivos relacionados (Código: KFM)

K250326Quantum Perfusion Centrifugal Blood Pump CP22NG with Integrated Sensors (CP22V-NG)Spectrum Medical S.R.L.K233091Quantum Perfusion Centrifugal Blood Pump CP37 with Integrated Sensors (CP37V-VT); Quantum Perfusion Centrifugal Blood Pump CP22 with Integrated Sensors (CP22V-VT)Qura S.R.L K232132LifeSPARC SystemCardiacassist, Inc.K220842Quantum Perfusion Centrifugal Blood Pump CP22 with Integrated Sensors, Quantum Perfusion Centrifugal Blood Pump CP20 with Integrated SensorsQura S.R.L K200091Capiox iCP Centrifugal PumpTerumo Cardiovascular Systems Corporation K201320Quantum PureFlow Centrifugal Blood Pump CP22 with Integrated SensorQura S.R.L

Fuente oficial

Ver en la base de datos de la FDA →

Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.