FDA 510(k)

Sol-Care Safety Blood Collection Needle with and without Pre-Attached Holder

Numéro K : K163073 · 2017-05-19

Date de décision2017-05-19

Code produitJKA

Comité consultatifCH

DécisionSubstantially Equivalent

Résumé du dispositif

Sol-Care Safety Blood Collection Needle with and without Pre-Attached Holder is the device name listed in this FDA 510(k) record. The listed applicant is Sol-Millennium Medical, Inc.. It received FDA 510(k) clearance on 2017-05-19 under 510(k) number K163073. 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 Sol-Care Safety Blood Collection Needle with and without Pre-Attached Holder?

Sol-Care Safety Blood Collection Needle with and without Pre-Attached Holder is a medical device that received FDA 510(k) clearance on 2017-05-19. The listed applicant is Sol-Millennium Medical, Inc.. The 510(k) number is K163073.

When did Sol-Care Safety Blood Collection Needle with and without Pre-Attached Holder receive FDA 510(k) clearance?

Sol-Care Safety Blood Collection Needle with and without Pre-Attached Holder received FDA 510(k) clearance on 2017-05-19, under 510(k) number K163073.

Who is the listed applicant for Sol-Care Safety Blood Collection Needle with and without Pre-Attached Holder?

The FDA 510(k) record lists Sol-Millennium Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Sol-Care Safety Blood Collection Needle with and without Pre-Attached Holder?

The FDA product code for Sol-Care Safety Blood Collection Needle with and without Pre-Attached Holder is JKA.

Essais cliniques associés

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Autres dossiers indiquant Sol-Millennium Medical, Inc. en tant que demandeur

K252184SOL-M Luer Lock Syringe with Exchangeable Needle Tray K253110Sol-Glide Safety Needle; Sol-Glide Safety Needle with Syringe K250907Sol-Guard TM XtraThin Safety Pull-Button Blood Collection Set K242291SOL-M Luer Lock Syringe (Low Dead Space) w/o Needle, SOL-M Slip Tip Syringe (Low Dead Space) w/o needle, SOL-M Luer Lock Syringe (Low Dead Space) w/Exchangeable Needle, SOL-CARE Luer Lock Syringe (Low Dead Space) w/Safety Needle, SOL-M Slip Tip Syringe (Low Dead Space) w/Exchangeable Needle K242099Sol-M™ Slip Tip Syringe without Needle, Sol-M™ Eccentric Tip Syringe without Needle K241821Luer Lock Syringe with Safety Needle; Luer Lock Syringe with Exchangeable Needle; Luer Lock Syringe with Blunt Fill Needle

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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 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

Source officielle

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