FDA 510(k)

BD Preset™ and BD A-Line™ Arterial Blood Collection Syringes

Número K: K260128 · 2026-04-15

Data da decisão2026-04-15

Código do produtoJKA

Comité consultivoCH

DecisãoSubstantially Equivalent

Resumo do dispositivo

BD Preset™ and BD A-Line™ Arterial Blood Collection Syringes is the device name listed in this FDA 510(k) record. The listed applicant is Becton, Dickinson and Company. It received FDA 510(k) clearance on 2026-04-15 under 510(k) number K260128. The device is classified under product code JKA. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the BD Preset™ and BD A-Line™ Arterial Blood Collection Syringes?

BD Preset™ and BD A-Line™ Arterial Blood Collection Syringes is a medical device that received FDA 510(k) clearance on 2026-04-15. The listed applicant is Becton, Dickinson and Company. The 510(k) number is K260128.

When did BD Preset™ and BD A-Line™ Arterial Blood Collection Syringes receive FDA 510(k) clearance?

BD Preset™ and BD A-Line™ Arterial Blood Collection Syringes received FDA 510(k) clearance on 2026-04-15, under 510(k) number K260128.

Who is the listed applicant for BD Preset™ and BD A-Line™ Arterial Blood Collection Syringes?

The FDA 510(k) record lists Becton, Dickinson and Company as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BD Preset™ and BD A-Line™ Arterial Blood Collection Syringes?

The FDA product code for BD Preset™ and BD A-Line™ Arterial Blood Collection Syringes is JKA.

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Outros registros que listam Becton, Dickinson and Company como candidato(a)

K262163BD BBL Mueller Hinton II Broth (Cation-Adjusted); BD Difco Mueller Hinton Broth K252506BD Vacutainer® Safety-Lok™ Blood Collection Set; BD Vacutainer® Safety-Lok™ Blood Collection Set with Pre-Attached Holder K252378BD® MiniDraw™ Capillary Blood Collection System with BD® MiniDraw™ SST™ Capillary Blood Collection Tube K260184Onclarity™ Self-Collection Kit K252040BD Vacutainer® Plasma Separator Tubes (PST™), BD Vacutainer® Sodium Heparin Blood Collection Tubes K250884Injeção de Sódio Clorídrico 0,9 %, USP, Siringa BD PosiFlush™ SP

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Dispositivos Relacionados (Código: JKA)

K262215Profoject™ Safety Sliding Blood Collection SetCMT Health PTE., Ltd.K252899Female Culture Device; Male Culture Device; Transfer Device; Access DeviceZhejiang Kindly Medical Device Co., Ltd.K252378BD® MiniDraw™ Capillary Blood Collection System with BD® MiniDraw™ SST™ Capillary Blood Collection TubeBecton, Dickinson and Company K252506BD Vacutainer® Safety-Lok™ Blood Collection Set; BD Vacutainer® Safety-Lok™ Blood Collection Set with Pre-Attached HolderBecton, Dickinson and Company K252040BD Vacutainer® Plasma Separator Tubes (PST™), BD Vacutainer® Sodium Heparin Blood Collection TubesBecton, Dickinson and Company K251812Steripath® Flow™ Blood Collection SystemMagnolia Medical Technologies

Fonte oficial

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