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FDA 510(k)

Safety butterfly type blood collection needle, Butterfly type blood collection needle, Pen type blood collection needle, Safety pen

K-Number: K213146 · 2023-10-27

ApplicantJiangsu Rongye Technology Co., Ltd.
Decision Date2023-10-27
Product CodeJKA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

Safety butterfly type blood collection needle, Butterfly type blood collection needle, Pen type blood collection needle, Safety pen is the device name listed in this FDA 510(k) record. The listed applicant is Jiangsu Rongye Technology Co., Ltd.. It received FDA 510(k) clearance on 2023-10-27 under 510(k) number K213146. 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 Safety butterfly type blood collection needle, Butterfly type blood collection needle, Pen type blood collection needle, Safety pen?

Safety butterfly type blood collection needle, Butterfly type blood collection needle, Pen type blood collection needle, Safety pen is a medical device that received FDA 510(k) clearance on 2023-10-27. The listed applicant is Jiangsu Rongye Technology Co., Ltd.. The 510(k) number is K213146.

When did Safety butterfly type blood collection needle, Butterfly type blood collection needle, Pen type blood collection needle, Safety pen receive FDA 510(k) clearance?

Safety butterfly type blood collection needle, Butterfly type blood collection needle, Pen type blood collection needle, Safety pen received FDA 510(k) clearance on 2023-10-27, under 510(k) number K213146.

Who is the listed applicant for Safety butterfly type blood collection needle, Butterfly type blood collection needle, Pen type blood collection needle, Safety pen?

The FDA 510(k) record lists Jiangsu Rongye Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Safety butterfly type blood collection needle, Butterfly type blood collection needle, Pen type blood collection needle, Safety pen?

The FDA product code for Safety butterfly type blood collection needle, Butterfly type blood collection needle, Pen type blood collection needle, Safety pen is JKA.

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

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

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