FDA 510(k)

Quantum PureFlow Standard Heat Exchanger Medium Flow 1/4 W

Número K: K252541 · 2026-03-12

Data da decisão2026-03-12

Código do produtoDTR

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

Quantum PureFlow Standard Heat Exchanger Medium Flow 1/4 W 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 2026-03-12 under 510(k) number K252541. The device is classified under product code DTR. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Quantum PureFlow Standard Heat Exchanger Medium Flow 1/4 W?

Quantum PureFlow Standard Heat Exchanger Medium Flow 1/4 W is a medical device that received FDA 510(k) clearance on 2026-03-12. The listed applicant is Spectrum Medical S.R.L.. The 510(k) number is K252541.

When did Quantum PureFlow Standard Heat Exchanger Medium Flow 1/4 W receive FDA 510(k) clearance?

Quantum PureFlow Standard Heat Exchanger Medium Flow 1/4 W received FDA 510(k) clearance on 2026-03-12, under 510(k) number K252541.

Who is the listed applicant for Quantum PureFlow Standard Heat Exchanger Medium Flow 1/4 W?

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 PureFlow Standard Heat Exchanger Medium Flow 1/4 W?

The FDA product code for Quantum PureFlow Standard Heat Exchanger Medium Flow 1/4 W is DTR.

Ensaios clínicos relacionados

Registros relacionados são pareados automaticamente usando nomes, códigos de produtos ou outros metadados. Um pareamento não estabelece um vínculo clínico, científico, corporativo ou regulatório verificado; revise as fontes oficiais vinculadas.

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

Outros registros que listam Spectrum Medical S.R.L. como candidato(a)

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);K251762Quantum Perfusion Centrifugal Blood Pump CP20NG with Integrated Sensors (CP20V-NG)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: DTR)

K240908Quantum Micro-Cardioplegia Delivery System; Quantum Micro-Cardioplegia Delivery Module (QMCDM)Spectrum Medical , Ltd.K250150VANGUARD Blood cardioplegia Systems (Vanguard 4:1 Blood cardioplegia set); VANGUARD Blood cardioplegia Systems (Vanguard 4:1 Blood cardioplegia set with shunt); VANGUARD Blood cardioplegia Systems (Vanguard 4:1 Blood Cardioplegia Set Mini)Sorin Group Italia S.R.L.K240190MYOtherm XP Cardioplegia Delivery System with Cortiva BioActive Surface, MYOtherm XP Cardioplegia Delivery System UncoatedMedtronic K223879Quantum PureFlow Standard Heat Exchangers (HX11W-S2, HX11W-S1M and HX11W-S2M)Quara S.R.L.K220110Quantum PureFlow Standard Heat Exchanger and Quantum PureFlow Cardioplegia Heat ExchangerQura S.R.L K212688Quantum PureFlow Standard Heat Exchanger, Quantum PureFlow Cardioplegia Heat ExchangerQura S.R.L

Fonte oficial

Ver na base de dados da FDA →

Dados provenientes da FDA Open API. Para informações mais recentes e oficiais, consulte sempre o registro oficial.