FDA 510(k)

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

N.º K: K260128 · 2026-04-15

SolicitanteBecton, Dickinson and Company

Fecha de decisión2026-04-15

Código de productoJKA

Comité asesorCH

DecisiónSubstantially Equivalent

Resumen del 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.

Preguntas frecuentes

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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Otros registros que enlistan a Becton, Dickinson and Company como solicitante

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 K250884Inyección de Cloruro de Sodio al 0.9 %, USP, Jeringa 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

Fuente oficial

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