FDA 510(k)

Profoject™ Safety Sliding Blood Collection Set

N.º K: K262215 · 2026-09-25

Fecha de decisión2026-09-25

Código de productoJKA

Comité asesorCH

DecisiónSubstantially Equivalent

Resumen del dispositivo

Profoject™ Safety Sliding Blood Collection Set is the device name listed in this FDA 510(k) record. The listed applicant is CMT Health PTE., Ltd.. It received FDA 510(k) clearance on 2026-09-25 under 510(k) number K262215. 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 Profoject™ Safety Sliding Blood Collection Set?

Profoject™ Safety Sliding Blood Collection Set is a medical device that received FDA 510(k) clearance on 2026-09-25. The listed applicant is CMT Health PTE., Ltd.. The 510(k) number is K262215.

When did Profoject™ Safety Sliding Blood Collection Set receive FDA 510(k) clearance?

Profoject™ Safety Sliding Blood Collection Set received FDA 510(k) clearance on 2026-09-25, under 510(k) number K262215.

Who is the listed applicant for Profoject™ Safety Sliding Blood Collection Set?

The FDA 510(k) record lists CMT Health PTE., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Profoject™ Safety Sliding Blood Collection Set?

The FDA product code for Profoject™ Safety Sliding Blood Collection Set is JKA.

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Otros registros que enlistan a CMT Health PTE., Ltd. como solicitante

K261372Profoject™ LOR Syringe K261829Profoject™ Dual-Safety Pen Needles K260739Profoject™ Pen Needles (Model A; Model B)K260514Profoject™ Safety Needle; Profoject™ Syringe with Safety Needle; Profoject™ Low Dead Space Syringe with Safety Needle K260855Profoject™ Safety Pen Needles K253268Profoject Enteral/Oral Feeding Syringe; Profoject Reusable Enteral/Oral Feeding Syringe (Model A, Model B); Profoject ENFit Adaptor; Profoject Enteral Feeding Syringes Cap

Ver todos los 12 dispositivos →

Dispositivos relacionados (Código: JKA)

K252899Female Culture Device; Male Culture Device; Transfer Device; Access DeviceZhejiang Kindly Medical Device Co., Ltd.K260128BD Preset™ and BD A-Line™ Arterial Blood Collection SyringesBecton, Dickinson and Company 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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