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FDA 510(k)

Kurin PIV Blood Collection Set with High Pressure

K-Number: K181895 · 2019-01-18

ApplicantKurin, Inc.
Decision Date2019-01-18
Product CodeJKA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

Kurin PIV Blood Collection Set with High Pressure is the device name listed in this FDA 510(k) record. The listed applicant is Kurin, Inc.. It received FDA 510(k) clearance on 2019-01-18 under 510(k) number K181895. 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 Kurin PIV Blood Collection Set with High Pressure?

Kurin PIV Blood Collection Set with High Pressure is a medical device that received FDA 510(k) clearance on 2019-01-18. The listed applicant is Kurin, Inc.. The 510(k) number is K181895.

When did Kurin PIV Blood Collection Set with High Pressure receive FDA 510(k) clearance?

Kurin PIV Blood Collection Set with High Pressure received FDA 510(k) clearance on 2019-01-18, under 510(k) number K181895.

Who is the listed applicant for Kurin PIV Blood Collection Set with High Pressure?

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

What is the FDA product code for Kurin PIV Blood Collection Set with High Pressure?

The FDA product code for Kurin PIV Blood Collection Set with High Pressure is JKA.

Other records listing Kurin, 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.

K220677Kurin Blood Culture Collection Set with Kurin Lock TechnologyK191832Kurin Blood Culture Collection Set with Kurin Lock Technology, Push-Button Needle (Product models M-21221, M-21223, D-21221, D-21223, T-21221, T-21223)

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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