FDA 510(k)

BD Vacutainer® Eclipse™ Blood Collection Needle

Numéro K : K243207 · 2025-07-03

Date de décision2025-07-03

Code produitJKA

Comité consultatifCH

DécisionSubstantially Equivalent

Résumé du dispositif

BD Vacutainer® Eclipse™ Blood Collection Needle 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 2025-07-03 under 510(k) number K243207. The device is classified under product code JKA. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the BD Vacutainer® Eclipse™ Blood Collection Needle?

BD Vacutainer® Eclipse™ Blood Collection Needle is a medical device that received FDA 510(k) clearance on 2025-07-03. The listed applicant is Becton, Dickinson and Company. The 510(k) number is K243207.

When did BD Vacutainer® Eclipse™ Blood Collection Needle receive FDA 510(k) clearance?

BD Vacutainer® Eclipse™ Blood Collection Needle received FDA 510(k) clearance on 2025-07-03, under 510(k) number K243207.

Who is the listed applicant for BD Vacutainer® Eclipse™ Blood Collection Needle?

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 Vacutainer® Eclipse™ Blood Collection Needle?

The FDA product code for BD Vacutainer® Eclipse™ Blood Collection Needle is JKA.

Essais cliniques associés

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Autres dossiers indiquant Becton, Dickinson and Company en tant que demandeur

K262163BD BBL Mueller Hinton II Broth (Cation-Adjusted); BD Difco Mueller Hinton Broth K260128BD Preset™ and BD A-Line™ Arterial Blood Collection Syringes 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

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Dispositifs connexes (Code : 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.K260128BD Preset™ and BD A-Line™ Arterial Blood Collection SyringesBecton, Dickinson and Company K252506BD Vacutainer® Safety-Lok™ Blood Collection Set; BD Vacutainer® Safety-Lok™ Blood Collection Set with Pre-Attached HolderBecton, Dickinson and Company K252378BD® MiniDraw™ Capillary Blood Collection System with BD® MiniDraw™ SST™ Capillary Blood Collection TubeBecton, Dickinson and Company K252040BD Vacutainer® Plasma Separator Tubes (PST™), BD Vacutainer® Sodium Heparin Blood Collection TubesBecton, Dickinson and Company

Source officielle

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