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FDA 510(k)

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

K-Number: K163073 · 2017-05-19

ApplicantSol-Millennium Medical, Inc.
Decision Date2017-05-19
Product CodeJKA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

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.

Frequently Asked Questions

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.

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Other records listing Sol-Millennium Medical, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253110Sol-Glide Safety Needle; Sol-Glide Safety Needle with SyringeK250907Sol-Guard TM XtraThin Safety Pull-Button Blood Collection SetK242291SOL-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 NeedleK242099Sol-M™ Slip Tip Syringe without Needle, Sol-M™ Eccentric Tip Syringe without NeedleK241821Luer Lock Syringe with Safety Needle; Luer Lock Syringe with Exchangeable Needle; Luer Lock Syringe with Blunt Fill NeedleK220713Sol-Guard Auto-disable Syringe

View all 12 devices →

Related Devices (Code: JKA)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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 CompanyK252506BD Vacutainer® Safety-Lok™ Blood Collection Set; BD Vacutainer® Safety-Lok™ Blood Collection Set with Pre-Attached HolderBecton, Dickinson and CompanyK252378BD® MiniDraw™ Capillary Blood Collection System with BD® MiniDraw™ SST™ Capillary Blood Collection TubeBecton, Dickinson and CompanyK252040BD Vacutainer® Plasma Separator Tubes (PST™), BD Vacutainer® Sodium Heparin Blood Collection TubesBecton, Dickinson and CompanyK251812Steripath® Flow™ Blood Collection SystemMagnolia Medical Technologies

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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